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phrmamedicinesindevelopmentcancer2012 (3)

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Pharmaceutical medicines in development for Cancer. A report listing the 900 products in development with company names and disease area
136
Few things cause more fear and apprehension than a cancer diagnosis. But today—because of early detection and a steady stream of new and improved treatments—cancer increasingly can be managed and even beaten. But patients and their families are looking for more and bet- ter treatments, and America’s biopharmaceuti- cal research companies are responding. Biopharmaceutical researchers are now work- ing on 981 medicines for cancer. Many are some involve innovative research into using existing medicines in new ways. Researchers’ deep commitment to patients and advancing science is at the core of the remark- - cancer deaths. The number of cancer survivors living in the United States has increased from 3 million in 1971 to nearly 12 million in 2008. The increase in survivors is attributed in large measure to earlier diagnosis and detection and better treatments and follow-up care. America’s biopharmaceutical research com- panies are working on many new cutting-edge - tabolism of cancer cells by depriving them of the energy provided by glucose. (AML) that inhibits cancer cells with a mutation found in about a third of AML sufferers. target the delivery of medicines to cancer cells, potentially overcoming some limita- tions of existing treatments. Despite recent progress, cancer remains the second leading cause of death by disease in the United States, exceeded only by heart people a day. The hundreds of new medicines to treat cancer now being developed are our best hope for lessening the burden of cancer to patients, their families and society. More Than 900 Medicines and Vaccines in Clinical Testing Offer New Hope in the Fight Against Cancer Medicines in Development CANCER PRESENTED BY AMERICAS BIOPHARMACEUTICAL RESEARCH COMPANIES 2012 REPORT 111 66 121 117 94 Lymphoma Colorectal Cancer Lung Cancer Prostate Cancer Breast Cancer 67 Skin Cancer Medicines in Development for Selected Cancer Types More Than 1.6 million New Cases of Cancer Are Expected This Year
Transcript
Page 1: phrmamedicinesindevelopmentcancer2012 (3)

Few things cause more fear and apprehension than a cancer diagnosis. But today—because of early detection and a steady stream of new and improved treatments—cancer increasingly can be managed and even beaten. But patients and their families are looking for more and bet-ter treatments, and America’s biopharmaceuti-cal research companies are responding.

Biopharmaceutical researchers are now work-ing on 981 medicines for cancer. Many are

some involve innovative research into using existing medicines in new ways.

Researchers’ deep commitment to patients and advancing science is at the core of the remark-

-

cancer deaths. The number of cancer survivors living in the United States has increased from 3 million in 1971 to nearly 12 million in 2008. The increase in survivors is attributed in large measure to earlier diagnosis and detection and better treatments and follow-up care.

America’s biopharmaceutical research com-panies are working on many new cutting-edge

-tabolism of cancer cells by depriving them of the energy provided by glucose.

(AML) that inhibits cancer cells with a mutation found in about a third of AML sufferers.

target the delivery of medicines to cancer cells, potentially overcoming some limita-tions of existing treatments.

Despite recent progress, cancer remains the second leading cause of death by disease in the United States, exceeded only by heart

people a day. The hundreds of new medicines to treat cancer now being developed are our best hope for lessening the burden of cancer to patients, their families and society.

More Than 900 Medicines and Vaccines in

Clinical Testing Offer New Hope in the Fight

Against Cancer

Medicines in Development

CANCER

PRESENTED BY AMERICA’S BIOPHARMACEUTICAL

RESEARCH COMPANIES

2012 RE

PO

RT

111

66

121117

94

Lym

phom

a

Col

orec

tal C

ance

rLu

ng C

ance

r

Pro

stat

e C

ance

r

Bre

ast C

ance

r

67

Ski

n C

ance

r

Medicines in Development

for Selected Cancer Types

More Than

1.6 million New Cases of Cancer Are Expected This Year

Page 2: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 20122

Lung Cancer

Liver Cancer

Leukemia

Kidney Cancer

Head/Neck Cancer

Colorectal Cancer

Cervical Cancer

Breast Cancer

Brain Cancer

Bladder Cancer 9

62

66

111

8

25

35

120

36

121

Multiple Myeloma

Lymphoma 117

57

Ovarian Cancer 63

Cancer-Related Conditions

Stomach Cancer

Solid Tumors

Skin Cancer

Sarcoma

Prostate Cancer

Pancreatic Cancer

94

58

21

67

280

23

38

Unspecified Cancer

Other Cancers 102

72

* Some medicines are listed in more than one category.

Medicines in Development for Cancer*

Medicines in Development for Cancer

BLADDER CANCER

Product Name Sponsor Indication Development Status*

Abraxane®

albumin-bound paclitaxelCelgeneSummit, NJ

second-line bladder cancer (see also breast, lung, ovarian, pancreatic, skin)

(908) 673-9000

AEZS-108 AEterna ZentarisBasking Ridge, NJ

(see also ovarian, prostate, other)

BC-819 (gene therapy)

BioCancell TherapeuticsJerusalem, Israel

(see also ovarian, pancreatic)www.biocancell.com

(mycobacterium cell wall-DNA complex)

Endo PharmaceuticalsChadds Ford, PA

non-muscle invasive bladder cancer(Fast Track)

Page 3: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 2012 3

BLADDER CANCE

Product Name Sponsor Indication Development Status

EOquin®

apaziquoneAllerganIrvine, CA

Spectrum PharmaceuticalsIrvine, CA

non-invasive bladder cancer(Fast Track)

Folotyn®

pralatrexate(Orphan Drug)

Allos TherapeuticsWestminster, CO

(see also breast, lung, lymphoma)

icrucumab Eli LillyIndianapolis, IN

Bridgewater, NJ

(see also breast, colorectal)

tesetaxel GentaBerkeley Heights, NJ

second-line bladder cancer (see also breast, prostate, skin, stomach)

(908) 286-9800

Viventia BiotechnologiesMississauga, Canada

(see also head/neck)

BRAIN CANCER

Product Name Sponsor Indication Development Status

United TherapeuticsSilver Spring, MD

(see also sarcoma, other)(301) 608-9292

ABT-888(veliparib)(PARP inhibitor)

Abbott LaboratoriesAbbott Park, IL

(see also breast, colorectal, lung, lymphoma, ovarian, prostate, skin, other)

(pan-HER inhibitor)Ambit BiosciencesSan Diego, CA

glioma(see also breast, lung)

AEE788 Novartis PharmaceuticalsEast Hanover, NJ

glioblastoma (888) 669-6682

afatinibPharmaceuticals

glioblastoma(see also breast, head/neck, lung)

APN301

fusion protein)

Apeiron BiologicsVienna, Austria

neuroblastoma in children(see also skin) www.apeiron-biologics.com

Medicines in Development for Cancer

Page 4: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 20124

BRAIN CANCER

Product Name Sponsor Indication Development Status

AR-67 Arno TherapeuticsFlemington, NJ

glioblastoma(see also leukemia, solid tumors) (862) 703-7170

ARC-100 Archer BiosciencesNew York, NY

glioblastoma (recurrent)(see also breast, prostate, skin)--------------------------------------------------neuroblastoma (combination therapy)--------------------------------------------------medulloblastoma (combination therapy)

-------------------------------------------

-------------------------------------------

AT-101(oral pan Bcl-2 inhibitor)

Ascenta TherapeuticsMalvern, PA

glioblastoma(see also leukemia, lung, lymphoma, prostate, stomach)

Avastin®

bevacizumabGenentechSouth San Francisco, CA (see also breast, colorectal, lung,

ovarian, other)

Azedra™

(Orphan Drug)Cambridge, MA

neuroblastoma (pediatric) (Fast Track), paraganglioma, pheochromocytoma (Fast Track)

bafetinib CytRx Los Angeles, CA

second-line brain cancer (see also leukemia, prostate)

BKM120 Novartis PharmaceuticalsEast Hanover, NJ

glioblastoma(see also breast, lung, other) (888) 669-6682

(Orphan Drug)

United TherapeuticsSilver Spring, MD

neuroblastoma (children)(301) 608-9292

cilengitide(Orphan Drug)

EMD SeronoRockland, MA

newly-diagnosed glioblastoma(combination therapy)(see also prostate)

(800) 283-8088

cintredekin besudotox(Orphan Drug) Phoenix, AZ

glioma (adolescents and children)(Fast Track) (602) 910-2617

Cotara®

monoclonal antibody TNT-1 (Orphan Drug)

Peregrine Pharmaceuticals recurrent glioblastoma(Fast Track)

CPP-1X Cancer Prevention Pharmaceuticals neuroblastoma

Medicines in Development for Cancer

Page 5: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 2012 5

BRAIN CANCER

Product Name Sponsor Indication Development Status

crenolanib AROG Pharmaceuticals glioma (adults)(see also stomach)--------------------------------------------------glioma (pediatric)

-------------------------------------------

DCVax®-Brain

brain cancer vaccine(Orphan Drug)

Northwest BiotherapeuticsBethesda, MD

glioblastoma

EisaiWoodcliff Lake, NJ

second-line glioblastoma (see also head/neck, liver, skin, solid tumors, stomach)

E7080(lenvatinib)

EisaiWoodcliff Lake, NJ

glioma(see also skin, other)

EPO-806(patupilone)

Novartis PharmaceuticalsEast Hanover, NJ

brain metastases from lung cancer(see also prostate) (888) 669-6682

G-100 prophage cancer vaccine(vitespen)(Orphan Drug)

AgenusLexington, MA

newly-diagnosed glioma

G-200 prophage cancer vaccine(vitespen)(Orphan Drug)

AgenusLexington, MA

recurrent glioma

GliAtak™gene therapy(Orphan Drug)

AdvantageneAuburndale, MA

glioma

--------------------------------------------------brain cancer (children)

-------------------------------------------

GMB-Vax

dendritic cell cancer vaccineActivartis BiotechVienna, Austria www.activartis.com

(LRP directed peptide-drugconjugate)

GeronMenlo Park, CA

brain metastases

--------------------------------------------------glioma

-------------------------------------------

(BRaf protein kinase inhibitor)GlaxoSmithKline brain metastases from melanoma

(see also lung, skin)

Hycamtin®

topotecanGlaxoSmithKline metastatic brain cancer

Medicines in Development for Cancer

Page 6: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 20126

Medicines in Development for Cancer

BRAIN CANCER

Product Name Sponsor Indication Development Status

(dendritic cell vaccine)(Orphan Drug)

Woodland Hills, CA

glioblastoma(818) 992-2907

Levulan® PDT

aminolevulinic acidDUSA PharmaceuticalsWilmington, MA

lonafarnib MerckWhitehouse Station, NJ

glioblastoma(800) 672-6372

Lucanix®

belagenpumatucel-LNovaRxSan Diego, CA

glioma(see also lung)

macitentan Actelion Pharmaceuticals USSouth San Francisco, CA

glioblastoma (combination therapy)

(anti-PDGFR-alpha mAb)AstraZenecaWilmington, DE

Gaithersburg, MD

glioblastoma(see also lung) (800) 236-9933

(301) 398-0000

mibefradil(T-type calcium channel inhibitor)(Orphan Drug)

Tau TherapeuticsCharlottesville, VA

glioblastoma

PharmacyclicsSunnyvale, CA

glioblastoma (combination therapy)

nimotuzumab(Orphan Drug)

YM Biosciences USALehigh Valley, PA

metastatic brain cancer, recurrent glioma (pediatric)(see also breast, prostate)

olaratumab(LY3012207)

Eli LillyIndianapolis, IN

Bridgewater, NJ

glioblastoma(see also ovarian)

Opaxio™paclitaxel poliglumex

Cell TherapeuticsSeattle, WA

glioma, glioblastoma(see also lung, ovarian, stomach, other)

perifosine AEterna ZentarisBasking Ridge, NJ

refractory metastatic glioma(see also colorectal, kidney, leukemia, lung, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach)

Page 7: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 2012 7

Medicines in Development for Cancer

BRAIN CANCER

Product Name Sponsor Indication Development Status

PLX3397(CSF-1R kinase inhibitor)

PlexxikonBerkeley, CA

recurrent glioblastoma(see also leukemia, lymphoma, solid tumors)

(Orphan Drug)

OncovirWashington, DC

anaplastic astrocytoma (adolescents and children), glioblastoma (adolescents and children)

www.oncovir.com

PX-866 OncothyreonSeattle, WA

second-line glioblastoma (see also head/neck, lung, prostate) (206) 801-2100

Reolysin®

reovirusOncolytics BiotechCalgary, Canada

glioma(see also colorectal, head/neck, lung, ovarian, pancreatic, sarcoma,skin, solid tumors)

rindopepimut(Orphan Drug)

Celldex TherapeuticsNeedham, MA (Fast Track)

--------------------------------------------------second-line glioblastoma (Fast Track)

-------------------------------------------

SB-313-xTZ Sangamo BiosciencesRichmond, CA

glioblastoma

SBG Biotec Pharmacon neuroblastoma (pediatric)www.biotec.no

SL-701(brain cancer vaccine)

Stemline TherapeuticsNew York, NY

glioma (adults)

--------------------------------------------------glioma (children)

(212) 831-1111-------------------------------------------

(212) 831-1111

SPRYCEL®

dasatinibBristol-Myers SquibbPrinceton, NJ

glioblastoma(see also breast, pancreatic, prostate, other)

in clinical trials

Tarceva®

erlotinib(Orphan Drug)

GenentechSouth San Francisco, CA

Farmingdale, NY

late-stage brain metastases, recurrent ependymoma (children), glioblastoma(see also breast, head/neck, leukemia, liver, lung, other)

(631) 962-0600

terameprocol Erimos Pharmaceuticals glioma (intravenous)(see also cervical, head/neck, solid tumors, other)

TGF-ß R1 inhibitor Eli LillyIndianapolis, IN

(see also liver)

Page 8: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 20128

BRAIN CANCER

Product Name Sponsor Indication Development Status

TH-302 Threshold PharmaceuticalsSouth San Francisco, CA

astrocytoma(see also leukemia, multiple myeloma, pancreatic, sarcoma)

(cytosine deaminase gene therapy)

TocagenSan Diego, CA

glioblastoma

trans-sodium crocetinate (TSC)(Orphan Drug)

Diffusion PharmaceuticalsCharlottesville, VA

gliobastoma

(cellular immunotherapyvaccine)

TVAX BiomedicalLenexa, KS

glioma

VAL-083 Del Mar PharmaceuticalsVancouver, Canada

VB-111 VBL TherapeuticsOr Yehuda, Israel

glioblastoma(see also other) www.vblrx.com

Xeloda®

capecitabineGenentechSouth San Francisco, CA

newly-diagnosed glioma (adolescents and children)(see also colorectal, liver, stomach)

Zelboraf®

vemurafenibGenentechSouth San Francisco, CA

PlexxikonBerkeley, CA

brain metastases(see also colorectal, other)

BREAST CANCER

Product Name Sponsor Indication Development Status

MerckWhitehouse Station, NJ

breast cancer (diagnosis)(800) 672-6372

Abraxane®

albumin-bound paclitaxelCelgeneSummit, NJ (see also bladder, lung, ovarian,

pancreatic, skin)(908) 673-9000

ABT-888 (veliparib)(PARP inhibitor)

Abbott LaboratoriesAbbott Park, IL

(see also brain, colorectal, lung, lymphoma, ovarian, prostate, skin, other)

(pan-HER inhibitor)Ambit BiosciencesSan Diego, CA

(see also brain, lung)

Medicines in Development for Cancer

Page 9: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 2012 9

BREAST CANCER

Product Name Sponsor Indication Development Status

acolbifene EndoCeuticsQuebec, Canada

AE37 peptide vaccine Antigen ExpressWorcester, MA

(see also ovarian)

afatinibPharmaceuticals

second-line metastatic breast cancer(see also brain, head/neck, lung)-------------------------------------------------- -------------------------------------------

ASCEND TherapeuticsHerndon, VA

breast cancer (prevention)

®

everolimusNovartis PharmaceuticalsEast Hanover, NJ

HER2-positive breast cancer(see also kidney, lymphoma) (888) 669-6682

KiraxBonita Springs, FL

amrubicin CelgeneSummit, NJ

late-stage breast cancer (see also lung) (908) 673-9000

ARC-100 Archer BiosciencesNew York, NY

(see also brain, prostate, skin)

ARRY-380(HER2 inhibitor)

Array BioPharmaBoulder, CO

AUY922(Hsp90 inhibitor)

Novartis PharmaceuticalsEast Hanover, NJ

breast cancer (monotherapy)(see also colorectal, lung, multiple myeloma, stomach)--------------------------------------------------breast cancer (combination therapy)

(888) 669-6682

-------------------------------------------

(888) 669-6682

Medicines in Development for Cancer

Page 10: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 201210

BREAST CANCER

Product Name Sponsor Indication Development Status

Avastin®

bevacizumabGenentechSouth San Francisco, CA

adjuvant HER2-negative breast can-cer, adjuvant HER2-positive breast cancer, adjuvant triple negative breast cancer(see also brain, colorectal, lung, ovarian, other)

AZD8931(erbB kinase inhibitor)

AstraZenecaWilmington, DE

advanced breast cancer (combination therapy)(see also solid tumors)

(800) 236-9933

(lonaprisan)Bayer HealthCare PharmaceuticalsWayne, NJ

metastatic breast cancer

Cambridge, MA

(see also stomach)(617) 679-2000

BKM120 Novartis PharmaceuticalsEast Hanover, NJ

second-line breast cancer(see also brain, lung, other) (888) 669-6682

breast cancer vaccine (dendritic cell vaccine)

brostallicin Cell TherapeuticsSeattle, WA

triple-negative breast cancer

BTSCAN Molecular Targeting TechnologiesWest Chester, PA

breast cancer (diagnosis)(610) 738-7938

BZL-101 BionovoEmeryville, CA

cabozantinib ExelixisSouth San Francisco, CA

(see also kidney, lung, ovarian, prostate, other)

cancer vaccine MabVax TherapeuticsSan Diego, CA

(see also sarcoma)

CDX-011(glembatumumab vedotin)

Celldex TherapeuticsNeedham, MA

breast cancer (Fast Track)(see also skin)

CV-301(cancer vaccine) Mountain View, CA

metastatic breast cancer

D-1MT NewLink GeneticsAmes, IA

second-line metastatic breast cancer(see also solid tumors)

Medicines in Development for Cancer

Page 11: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 2012 11

BREAST CANCER

Product Name Sponsor Indication Development Status

dalotuzumab MerckWhitehouse Station, NJ

second-line breast cancer (combination therapy)(see also lung, pancreatic, other)--------------------------------------------------

(800) 672-6372

-------------------------------------------

(800) 672-6372

DPX-0907Halifax, Canada

(see also ovarian, prostate)

eniluracil Adherex Technologies metastatic breast cancer(combination therapy)

entinostat Syndax PharmaceuticalsWaltham, MA

(see also colorectal, kidney, leukemia, lung, lymphoma)

etirinotecan pegol (NKTR-102)

Nektar TherapeuticsSan Francisco, CA

metastatic breast cancer(see also colorectal, ovarian, solid tumors)

EZN-2208 Enzon PharmaceuticalsPiscataway, NJ

metastatic breast cancer(see also colorectal, solid tumors)

Faslodex®

fulvestrantAstraZenecaWilmington, DE (800) 236-9933

folate binding protein (E39) vaccine

Galena BiopharmaLake Oswego, OR

(see also ovarian, other)

Folotyn®pralatrexate

Allos TherapeuticsWestminster, CO

(see also bladder, lung, lymphoma)

ganetespib (Hsp90i)

Synta PharmaceuticalsLexington, MA

(see also colorectal, leukemia, liver, lung, multiple myeloma, pancreatic, prostate, skin, stomach)

ganitumab Amgen combination therapy(see also colorectal, lung, pancreatic, sarcoma)

GDC-0980

inhibitor)

GenentechSouth San Francisco, CA

hormone receptor-positive breast cancer(see also lymphoma, solid tumors)

immunotherapeutic)

GlaxoSmithKline neoadjuvant breast cancer

GVAX® Breast

cancer vaccineBioSante PharmaceuticalsLincolnshire, IL

Medicines in Development for Cancer

Page 12: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 201212

BREAST CANCER

Product Name Sponsor Indication Development Status

immunotherapeuticGlaxoSmithKline

icrucumab Eli LillyIndianapolis, IN

Bridgewater, NJ

metastatic breast cancer(see also bladder, colorectal)

imetelstat GeronMenlo Park, CA

metastatic breast cancer(combination therapy)(see also leukemia, lung, multiple myeloma)

vaccine Doylestown, PA

(see also ovarian)

indibulinNew York, NY

late-stage breast cancer

iniparibBridgewater, NJ

neoadjuvant breast cancer(see also lung, ovarian)

Kyowa Hakko Kirin PharmaPrinceton, NJ breast cancer (609) 919-1100

LFA102(anti-prolactin receptor anti-body)

Novartis PharmaceuticalsEast Hanover, NJ

XOMABerkeley, CA

(see also prostate)(888) 669-6682

inhibitor)

Novartis PharmaceuticalsEast Hanover, NJ

(see also skin)(888) 669-6682

linifanib Abbott LaboratoriesAbbott Park, IL

breast cancer (combination therapy)(see also colorectal, kidney, liver, lung)

liposome encapsulated paclitaxel (LEP-ETU) Phoenix, AZ (602) 910-2617

litronesib Eli LillyIndianapolis, IN

metastatic breast cancer(see also lung)

Lorus Therapeutics metastatic breast cancer(see also colorectal, kidney, leukemia, prostate)

Lymphoseek®

Tc-99m tilmanoceptNavidea PharmaceuticalsDublin, OH

breast cancer (diagnosis)(see also head/neck, skin)

application submitted

Medicines in Development for Cancer

Page 13: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 2012 13

BREAST CANCER

Product Name Sponsor Indication Development Status

maraciclatide GE HealthcareWaukesha, WI

breast cancer (diagnosis) in clinical trialswww.gehealthcare.com

(notch signaling pathway inhibitor)

MerckWhitehouse Station, NJ

early-stage breast cancer, late-stage breast cancer(see also other)

(800) 672-6372

MK-2206(c-akt inhibitor)

MerckWhitehouse Station, NJ

HER2-positive breast cancer(see also other) (800) 672-6372

MM-111 Merrimack PharmaceuticalsCambridge, MA

breast cancer (combination therapy)

MM-302(anti-HER2 antibody doxorubicin conjugate)

Merrimack PharmaceuticalsCambridge, MA

motesanib Amgen (see also colorectal, lung, other)

MVA-BN® HER2

(HER-2/neu-based MVA vaccine)

Mountain View, CA

Myocet™doxorubicin liposomal

Sopherion TherapeuticsPrinceton, NJ (combination therapy) (Fast Track) (609) 986-2020

NeuVax™ Galena BiopharmaLake Oswego, OR

early-stage breast cancer(prevention of relapse)(see also prostate)

Nexavar®

sorafenibBayer HealthCare PharmaceuticalsWayne, NJ

(see also colorectal, head/neck, kidney, leukemia, liver, lung, multiple myeloma, ovarian, other)

nimotuzumab YM Biosciences USALehigh Valley, PA

(see also brain, prostate)

NK-012 Nippon Kayaku (see also lung)www.nipponkayaku.co.jp

OBP-301 Oncolys Biopharma (see also head/neck, liver, lung)www.oncolys.com

OncoGenex PharmaceuticalsBothell, WA

(see also lung, ovarian)

Medicines in Development for Cancer

Page 14: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 201214

BREAST CANCER

Product Name Sponsor Indication Development Status

onartuzumab GenentechSouth San Francisco, CA

metastatic breast cancer (combination therapy)(see also colorectal, lung)

OPT-822/OPT-821 Optimer BiotechnologySan Diego, CA

PB-272 (neratinib) Puma BiotechnologyLos Angeles, CA

second-line breast cancer, neoadjuvant breast cancer

pertuzumab GenentechSouth San Francisco, CA

--------------------------------------------------second-line late-stage breast cancer

application submitted

-------------------------------------------

pertuzumab companion diagnostic

DakoGlostrup, Denmark

GenentechSouth San Francisco, CA

breast cancer (diagnostic)www.dako.com

pertuzumab companiondiagnostic(HercepTest™)

DakoGlostrup, Denmark

GenentechSouth San Francisco, CA

breast cancer (diagnosis)www.dako.com

pixantrone Cell TherapeuticsSeattle, WA

breast cancer (Fast Track)(see also lymphoma)

PTC299 PTC Therapeutics (see also solid tumors, other)(908) 222-7000

Quinamed® CephalonFrazer, PA

(see also ovarian, prostate)

ramucirumab Eli LillyIndianapolis, IN

Bridgewater, NJ

metastatic breast cancer(see also colorectal, stomach)

Reximmune-C®

personalized cancer vaccineEpeius BiotechnologiesSan Marino, CA

Rexin-G® Epeius BiotechnologiesSan Marino, CA

metastatic breast cancer(see also pancreatic, sarcoma)

Medicines in Development for Cancer

Page 15: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 2012 15

BREAST CANCER

Product Name Sponsor Indication Development Status

ridaforolimusCambridge, MA

MerckWhitehouse Station, NJ

metastatic breast cancer(see also kidney, lung, prostate, sarcoma, other)

(800) 672-6372

rucaparib Clovis OncologyBoulder, CO

(see also ovarian)

sagopilone Bayer HealthCare PharmaceuticalsWayne, NJ

(see also ovarian, prostate)

injectionEUSA PharmaLanghorne, PA

(see also multiple myeloma, prostate, sarcoma, other)

Bridgewater, NJ

Exelixis South San Francisco, CA

(see also other)

Bridgewater, NJ

Exelixis South San Francisco, CA

(see also lymphoma)

(MM-121)(anti-ErbB3 mAb)

Merrimack PharmaceuticalsCambridge, MA

Bridgewater, NJ

(see also lung, ovarian)

SF1 (sonodynamic therapy) SonneMedBoston, MA

advanced breast cancerwww.sonnemed.com

SPRYCEL®

dasatinibBristol-Myers SquibbPrinceton, NJ

(see also brain, pancreatic, prostate, other)

in clinical trials

Menlo Park, CA

Tarceva®

erlotinibGenentechSouth San Francisco, CA

Farmingdale, NY

(see also brain, head/neck, leukemia, liver, lung, other)

(631) 962-0600

tesetaxel GentaBerkeley Heights, NJ (see also bladder, prostate, skin,

stomach)(908) 286-9800

Medicines in Development for Cancer

Page 16: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 201216

BREAST CANCER

Product Name Sponsor Indication Development Status

ThermoDox®

doxorubicin liposomalCelsionLawrenceville, NJ

recurrent breast cancer(see also colorectal, liver) (609) 896-9100

tigatuzumab Daiichi SankyoParsippany, NJ

(see also colorectal, liver, lymphoma, ovarian, pancreatic)

tivozanib Astellas Pharma US

AVEO PharmaceuticalsCambridge, MA

breast cancer (combination therapy)(see also colorectal, kidney)

(dovitinib)Novartis PharmaceuticalsEast Hanover, NJ

metastatic breast cancer(see also kidney, multiple myeloma, prostate, skin, other)

(888) 669-6682

trabectedin Johnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ

metastatic breast cancer (see also ovarian, prostate, sarcoma)

trastuzumab-DM1 GenentechSouth San Francisco, CA

trastuzumab-DM1 companion diagnostic(HercepTest™)

DakoGlostrup, Denmark

GenentechSouth San Francisco, CA

breast cancer (diagnosis)www.dako.com

trastuzumab-DM1 companion diagnostic

DakoGlostrup, Denmark

GenentechSouth San Francisco, CA

breast cancer (diagnosis)www.dako.com

(ENG protein inhibitor)TRACON PharmaceuticalsSan Diego, CA

(see also ovarian, prostate, other)

trebananib (AMG386)

Amgen (see also colorectal, kidney, liver, ovarian, stomach, other)

Tykerb®

lapatinibGlaxoSmithKline

(see also colorectal, head/neck, stomach)--------------------------------------------------

metastatic breast cancer--------------------------------------------------neoadjuvant breast cancer

application submitted

-------------------------------------------

-------------------------------------------

upamostat Munich, Germany www.wilex.de

Medicines in Development for Cancer

Page 17: phrmamedicinesindevelopmentcancer2012 (3)

Medicines in Development Cancer 2012 17

BREAST CANCER

Product Name Sponsor Indication Development Status

varlitinib ASLAN PharmaceuticalsSingapore www.aslanpharma.com

VeriStrat®

companion diagnostic testBiodesixBoulder, CO

advanced breast cancer (diagnosis-outcome test in HER2-overexpressing tumors)

(sepantronium)Astellas Pharma US (see also lymphoma)

Zolinza®

vorinostatMerckWhitehouse Station, NJ

(see also leukemia, lung, lymphoma, multiple myeloma, other) (800) 672-6273

Zytiga®

abirateroneJanssen BiotechHorsham, PA

second-line metastatic breast cancer(see also prostate)

CERVICAL CANCER

Product Name Sponsor Indication Development Status

ADXS-HPV AdvaxisPrinceton, NJ

cervical cancer, cervical intraepithelial neoplasia

PharmaMarMadrid, Spain

(see also sarcoma, other)www.pharmamar.com

PV701(replication-competent oncolytic virus)

Gaithersburg, MD

(see also colorectal)

terameprocol Erimos Pharmaceuticals cervical intraepithelial neoplasia (intravaginal)(see also brain, head/neck, solid tumors, other)

(HPV virus-like particle (VLP) vaccine)

MerckWhitehouse Station, NJ

prevention of cervical cancer, prevention of vulvovaginal cancer (800) 672-6372

(HPV vaccine)MerckWhitehouse Station, NJ

prevention of cervical cancer(800) 672-6372

Medicines in Development for Cancer

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Medicines in Development Cancer 201218

CERVICAL CANCER

Product Name Sponsor Indication Development Status

verpasep caltespen(cancer vaccine)

Akela Pharma cervical intraepithelial neoplasia

VGX-3100(DNA cancer vaccine) Blue Bell, PA

cervical intraepithelial neoplasia

COLORECTAL CANCER

Product Name Sponsor Indication Development Status

ABT-888 (veliparib)(PARP inhibitor)

Abbott LaboratoriesAbbott Park, IL

(see also brain, breast, lung, lymphoma, ovarian, prostate, skin, other)

Aptocine™ Light Sciences OncologyBellevue, WA

metastatic colorectal cancer

AUY922(Hsp90 inhibitor)

Novartis PharmaceuticalsEast Hanover, NJ

second-line colorectal cancer (combination therapy)(see also breast, lung, multiplemyeloma, stomach)

(888) 669-6682

Avastin®

bevacizumabGenentechSouth San Francisco, CA

metastatic colorectal cancer (treatment beyond progression) (see also brain, breast, lung, ovarian, other)

AVX701(CEA cancer immunotherapy)

AlphaVax colorectal cancer prevention in patients with advanced or metastatic CEA-expressing malignancies

belinostat Spectrum PharmaceuticalsHenderson, NV

colorectal cancer (combination therapy)(see also leukemia, liver, lung, lymphoma, ovarian, other)

brivanib(VEGFR/FGFR kinase inhibitor)

Bristol-Myers SquibbPrinceton, NJ

metastatic colorectal cancer(see also liver, sarcoma)

CPX-1 Celator PharmaceuticalsPrinceton, NJ

CT-011 CureTechYavne, Israel (combination therapy)

(see also leukemia, lymphoma)www.curetechbio.com

E7820 EisaiWoodcliff Lake, NJ

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 19

COLORECTAL CANCER

Product Name Sponsor Indication Development Status

efatutazone Daiichi SankyoParsippany, NJ

metastatic colorectal cancer(see also lung, other)

EGEN-001 EGENHuntsville, AL

(see also ovarian, other)

EGFR antagonist companion diagnostic Valencia, CA

colorectal cancer (diagnosis) application submittedwww.qiagen.com

encapsulated cell therapy(macrobeads) New York, NY

refractory metastatic colorectal cancer(see also pancreatic, prostate)

entinostat Syndax PharmaceuticalsWaltham, MA

metastatic colorectal cancer(combination therapy)(see also breast, kidney, leukemia, lung, lymphoma)

ERBITUX®

cetuximabBristol-Myers SquibbPrinceton, NJ

Eli LillyIndianapolis, IN

(see also stomach)in clinical trials

etirinotecan pegol(NKTR-102)

Nektar TherapeuticsSan Francisco, CA

second-line colorectal cancer(see also breast, ovarian, solid tumors)

EZN-2208 Enzon PharmaceuticalsPiscataway, NJ

metastatic colorectal cancer(see also breast, solid tumors)

FANG™ Vaccine

autologous tumor cell vaccineGradalis (see also ovarian, skin)

ganetespib (Hsp90i)

Synta PharmaceuticalsLexington, MA

refractory, metastatic colorectal cancer(see also breast, leukemia, liver, lung, multiple myeloma, pancreatic, prostate, skin, stomach)

ganitumab Amgen second-line metastatic colorectal cancer (combination therapy)(see also breast, lung, pancreatic, sarcoma)

(cancer vaccine) Louisville, CO

(see also lung, pancreatic)

Medicines in Development for Cancer

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Medicines in Development Cancer 201220

COLORECTAL CANCER

Product Name Sponsor Indication Development Status

GM-CT-01 Galectin TherapeuticsNewton, MA

colorectal cancer (combination therapy)

(monoclonal antibody)Gilead SciencesFoster City, CA

(see also pancreatic)

GVAX® Colorectal

cancer vaccineBioSante PharmaceuticalsLincolnshire, IL

icrucumab Eli LillyIndianapolis, IN

Bridgewater, NJ

(see also bladder, breast)

(TLR9 agonist) Cambridge, MA

(see also head/neck, lung)

Imprime PGG® BiotheraEagan, MN

(see also leukemia, lung, skin)

(pexastimogene devacirepvec)Jennerex BiotherapeuticsSan Francisco, CA

(see also liver)

KRN-330 Kyowa Hakko Kirin PharmaPrinceton, NJ

colorectal cancer (combination therapy)--------------------------------------------------colorectal cancer (monotherapy)

(609) 919-1100-------------------------------------------

(609) 919-1100

Morris Plains, NJ

labetuzumab-SN-38Morris Plains, NJ

LGX818(RAF inhibitor)

Novartis PharmaceuticalsEast Hanover, NJ

metastatic colorectal cancer(see also skin) (888) 669-6682

linifanib Abbott LaboratoriesAbbott Park, IL

second-line colorectal cancer(see also breast, kidney, liver, lung)

Lorus Therapeutics metastatic colorectal cancer(see also breast, kidney, leukemia, prostate)

motesanib Amgen (see also breast, lung, other)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 21

COLORECTAL CANCER

Product Name Sponsor Indication Development Status

Nexavar®

sorafenibBayer HealthCare PharmaceuticalsWayne, NJ

metastatic colorectal cancer (see also breast, head/neck, kidney, leukemia, liver, lung, multiple myeloma, ovarian, other)

NPC-1C(ensituximab)

Neogenix OncologyRockville, MD

metastatic colorectal cancer(see also pancreatic) (301) 917-6893

onartuzumab GenentechSouth San Francisco, CA

(see also breast, lung)

OncoVAX® VaccinogenFrederick, MD

(Fast Track)

perifosine AEterna ZentarisBasking Ridge, NJ

refractory metastatic colorectal cancer (combination therapy)(Fast Track)(see also brain, kidney, leukemia, lung, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach)

PHY906 PhytoCeutica (see also liver, pancreatic, cancer-related)

picoplatin Ponaird PharmaceuticalsSeattle, WA

(see also lung, ovarian, prostate)(206) 281-7001

polyclonal antibody stimulator Cancer AdvancesDurham, NC

(see also pancreatic, stomach)(919) 361-2162

PV701(replication-competent oncolytic virus)

Gaithersburg, MD

(see also cervical)

ramucirumab Eli LillyIndianapolis, IN

Bridgewater, NJ

(see also breast, stomach)

regorafenib Bayer HealthCare PharmaceuticalsWayne, NJ

metastatic colorectal cancer (Fast Track)(see also kidney, lung, solid tumors, stomach)

Reolysin®

reovirusOncolytics BiotechCalgary, Canada

(see also brain, head/neck, lung, ovarian, pancreatic, sarcoma,skin, solid tumors)

Medicines in Development for Cancer

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Medicines in Development Cancer 201222

COLORECTAL CANCER

Product Name Sponsor Indication Development Status

RG7160(EGFR inhibitor)

RocheNutley, NJ

second-line metastatic colorectal cancer (combination therapy)

(EGFL7 inhibitor)GenentechSouth San Francisco, CA

(see also lung)

RIGScan™

monoclonal antibody targeting agent

Navidea BiopharmaceuticalsDublin, OH

metastatic colorectal cancer (diagnosis)

application submitted(800) 793-0079

robatumumab MerckWhitehouse Station, NJ

(see also sarcoma, solid tumors)(800) 672-6372

SymphogenLyngby, Denmark

metastatic colorectal cancerwww.symphogen.com

TAS-102 Taiho Pharma U.S.A.Princeton, NJ

telatinib ACT BiotechSan Francisco, CA

(see also stomach)

TF2(pretargeted radioimmuno-therapy)

Morris Plains, NJ

colorectal cancer

ThermoDox®

doxorubicin liposomalCelsionLawrenceville, NJ

adjuvant inoperable/unresectable, metastatic colorectal cancer(see also breast, liver)

(609) 896-9100

tigatuzumab Daiichi SankyoParsippany, NJ

(see also breast, liver, lymphoma, ovarian, pancreatic)

tivantinib (ARQ 197)

ArQuleWoburn, MA

Daiichi SankyoParsippany, NJ

(see also kidney, liver, lung, pancreatic, sarcoma, other)

tivozanib Astellas Pharma US

AVEO PharmaceuticalsCambridge, MA

colorectal cancer (combination therapy)(see also breast, kidney)

trebananib (AMG386)

Amgen (see also breast, kidney, liver, ovarian, stomach, other)

Tykerb®

lapatinibGlaxoSmithKline metastatic colorectal cancer

(see also breast, head/neck, stomach)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 23

COLORECTAL CANCER

Product Name Sponsor Indication Development Status

Vectibix®

panitumumabAmgen

cancer (see also head/neck)

application submitted

Xeloda®

capecitabineGenentechSouth San Francisco, CA colorectal cancer

(combination therapy)(see also brain, liver, stomach)

application submitted

Zaltrap™ Regeneron Pharmaceuticals

Bridgewater, NJ

second-line metastatic colorectal cancer(see also prostate)

application submitted

Zelboraf®

vemurafenibGenentechSouth San Francisco, CA

PlexxikonBerkeley, CA

(see also brain, other)

HEAD/NECK CANCER

Product Name Sponsor Indication Development Status

(dalantercept)Acceleron PharmaCambridge, MA

(see also multiple myeloma)

afatinibPharmaceuticals

second-line head/neck cancer(see also breast, brain, lung)

Access Pharmaceuticals

EisaiWoodcliff Lake, NJ

(see also brain, liver, skin, solid tumors, stomach)

foretinib(GSK1363089)

GlaxoSmithKline (see also kidney, liver, lung)

GL-0810(Orphan Drug)

GliknikBaltimore, MD www.gliknik.com

GL-0817(Orphan Drug)

GliknikBaltimore, MD

(see also multiple myeloma)www.gliknik.com

HF-10 Takara BioShiga, Japan www.takara-bio.com

Medicines in Development for Cancer

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Medicines in Development Cancer 201224

HEAD/NECK CANCER

Product Name Sponsor Indication Development Status

(TLR9 agonist) Cambridge, MA

second-line head and neck cancer(combination therapy)(see also colorectal, lung)

New York, NY

(Fast Track)

Lymphoseek®

Tc-99m tilmanoceptNavidea PharmaceuticalsDublin, OH

head and neck cancer (diagnosis)(see also breast, skin)

Multikine®

leukocyte interleukin(Orphan Drug)

Vienna, VA

Nexavar®

sorafenibBayer HealthCare PharmaceuticalsWayne, NJ

(see also breast, colorectal, kidney, leukemia, liver, lung, multiple myeloma, ovarian, other)

OBP-301 Oncolys Biopharma (see also breast, liver, lung)www.oncolys.com

PX-866 OncothyreonSeattle, WA

head and neck cancer (combination therapy)(see also brain, lung, prostate)

(206) 801-2100

Reolysin®

reovirusOncolytics BiotechCalgary, Canada

metastatic head and neck cancer (combination therapy)(see also brain, colorectal, lung, ovarian, pancreatic, sarcoma, skin, solid tumors)

(EGFR antagonist)GenentechSouth San Francisco, CA

seliciclib(CYC202)

Cyclacel PharmaceuticalsBerkeley Heights, NJ

nasopharyngeal cancer (see also solid tumors)

Tarceva®

erlotinibGenentechSouth San Francisco, CA

Farmingdale, NY

(combination therapy)(see also brain, breast, leukemia,liver, lung, other)

(631) 962-0600

TAS-106 Taiho Pharma U.S.A.Princeton, NJ

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 25

HEAD/NECK CANCER

Product Name Sponsor Indication Development Status

terameprocol Erimos Pharmaceuticals head and neck cancer (intratumoral)(see also brain, cervical, solid tumors, other)

TNFerade™golnerminogene pradenovec

GenVecGaithersburg, MD

(see also prostate, skin, stomach)

Tykerb®

lapatinibGlaxoSmithKline head and neck squamous cell

carcinoma (resectable disease)(see also breast, colorectal, stomach)

(Orphan Drug)

Viventia BiotechnologiesMississauga, Canada

(Fast Track)(see also bladder)

Vectibix®

panitumumabAmgen

(see also colorectal)--------------------------------------------------second-line head and neck cancer

-------------------------------------------

KIDNEY CANCER

Product Name Sponsor Indication Development Status

®

everolimusNovartis PharmaceuticalsEast Hanover, NJ

hepatocellular carcinoma(see also breast, lymphoma) (888) 669-6682

AGS-003(personalized dendritic cell vaccine)

Argos TherapeuticsDurham, NC

renal cancer (combination therapy)(Fast Track)--------------------------------------------------metastatic renal cancer (monotherapy)

(919) 287-6300-------------------------------------------

(919) 287-6300

AMG 172 Amgen

anti-PD1 Bristol-Myers SquibbPrinceton, NJ

renal cell carcinoma(see also lung, skin)

Bionomicswww.bionomics.com.au

cabozantinib ExelixisSouth San Francisco, CA

renal cell carcinoma(see also breast, lung, ovarian, prostate, other)

Medicines in Development for Cancer

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Medicines in Development Cancer 201226

KIDNEY CANCER

Product Name Sponsor Indication Development Status

CVX 060

(Ang2 antagonist)New York, NY

renal cell carcinoma(see also solid tumors)

CYT107(interleukin-7)

CytherisRockville, MD

(see also skin)

entinostat Syndax PharmaceuticalsWaltham, MA

(see also breast, colorectal, leukemia, lung, lymphoma)

foretinib(GSK1363089)

GlaxoSmithKline (see also head/neck, liver, lung)

(cancer vaccine)immatics biotechnologies renal cancer

www.immatics.com

Inlyta®

axitinib(Orphan Drug)

New York, NY

advanced renal cell carcinoma in treatment-naive patients(see also liver, other)

Istodax®

romidepsinCelgeneSummit, NJ

renal cancer(see also pancreatic, prostate, other) (908) 673-9000

(panobinostat)Novartis PharmaceuticalsEast Hanover, NJ

renal cancer(see also leukemia, multiple myeloma, prostate, solid tumors)

(888) 669-6682

linifanib Abbott LaboratoriesAbbott Park, IL

renal cancer (see also breast, colorectal, liver, lung)

(Orphan Drug)

Lorus Therapeutics metastatic renal cancer(see also breast, colorectal, leukemia, prostate)

naptumomab estafenatox Active BiotechLund, Sweden

(see also lung, pancreatic)www.activebiotech.com

Nexavar®

sorafenibBayer HealthCare PharmaceuticalsWayne, NJ

renal cell carcinoma (adjuvant therapy)(see also breast, colorectal, head/neck, leukemia, liver, lung, multiple myeloma, ovarian, other)

Oncophage®

vitespen(Orphan Drug)

AgenusLexington, MA

renal cell carcinoma (Fast Track)

(TORC1/TORC2 inhibitor) Farmingdale, NY

renal cancer(see also lymphoma) (631) 962-0600

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 27

KIDNEY CANCER

Product Name Sponsor Indication Development Status

perifosine AEterna ZentarisBasking Ridge, NJ

metastatic renal cancer(see also brain, colorectal, leukemia, lung, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach)

Redectane®

companion diagnosticMunich, Germany

renal cancer (diagnosis)www.wilex.de

regorafenib Bayer HealthCare PharmaceuticalsWayne, NJ

renal cancer(see also colorectal, lung, solid tumors, stomach)

Rencarex®

girentuximab(Orphan Drug)

Munich, Germany

clear cell renal cell carcinoma(Fast Track) www.wilex.de

ridaforolimusCambridge, MA

MerckWhitehouse Station, NJ

(see also breast, lung, prostate, sarcoma, other) (800) 672-6372

(vorsetuzumab mafodotin)Seattle GeneticsBothell, WA

renal cancer(see also lymphoma)

Sutent®

sunitinib(Orphan Drug)

New York, NY

renal cell carcinoma (adjuvant therapy)

tivantinib (ARQ 197)

ArQuleWoburn, MA

Daiichi SankyoParsippany, NJ

(see also colorectal, liver, lung, pancreatic, sarcoma, other)

tivozanib Astellas Pharma US

AVEO PharmaceuticalsCambridge, MA

(see also breast, colorectal)

--------------------------------------------------renal cancer(combination therapy)

-------------------------------------------

(dovitinib)Novartis PharmaceuticalsEast Hanover, NJ

(see also breast, multiple myeloma, prostate, skin, other) (888) 669-6682

Torisel®

temsirolimus(Orphan Drug)

New York, NY

renal cell carcinoma

trebananib (AMG386)

Amgen renal cancer(see also breast, colorectal, liver, ovarian, stomach, other)

Medicines in Development for Cancer

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Medicines in Development Cancer 201228

KIDNEY CANCER

Product Name Sponsor Indication Development Status

(cellular immunotherapyvaccine)

TVAX BiomedicalLenexa, KS

renal cell carcinoma

veglin (VEGF antisense)

VasGene TherapeuticsLos Angeles, CA

(see also lung, skin)(323) 221-7818

Votrient™pazopanib

GlaxoSmithKline (see also ovarian, other)

LEUKEMIA

Product Name Sponsor Indication Development Status

Abiogen PharmaPisa, Italy

chronic myeloid leukemia (CML)www.abiogen.it

AC220(quizartinib)

Ambit BiosciencesSan Diego, CA

Astellas Pharma US

second-line and third-line acute myeloid leukemia (AML) (monotherapy)(see also solid tumors)--------------------------------------------------acute lymphocytic leukemia (ALL)

-------------------------------------------

(JAK2 inhibitor)Ambit BiosciencesSan Diego, CA

Adcetris™brentuximab vedotin

Millennium PharmaceuticalsCambridge, MA

Seattle GeneticsBothell, WA

(see also lymphoma)

Aegera TherapeuticsMontreal, Canada

AML(see also lymphoma)--------------------------------------------------chronic lymphocytic leukemia (CLL)

-------------------------------------------

Afecta PharmaceuticalsIrvine, CA

in clinical trials

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 29

LEUKEMIA

Product Name Sponsor Indication Development Status

Argos TherapeuticsDurham, NC

CLL(919) 287-6300

AldagenDurham, NC

ALXN6000(samalizumab)

Alexion Pharmaceuticals CLL(see also multiple myeloma)

aminopterin Syntrix BiosystemsAuburn, WA

ALL

anti-CD22/CD19 mAb-toxinconjugate

Abiogen PharmaPisa, Italy

ALLwww.abiogen.com

Arno TherapeuticsFlemington, NJ

CLL(see also lymphoma, multiple myeloma)

(862) 703-7170

AR-67 Arno TherapeuticsFlemington, NJ

myelodysplastic syndromes(see also brain, solid tumors) (862) 703-7170

Arranon®

nelarabine(Orphan Drug)

GlaxoSmithKline(see also lymphoma)--------------------------------------------------second-line ALL

(888) 669-6682-------------------------------------------

(888) 669-6682

(KSP inhibitor)Array BioPharmaBoulder, CO

AML(see also multiple myeloma, solid tumors)

Arzerra®

ofatumumab(Orphan Drug)

GlaxoSmithKline(see also lymphoma)

AT-101(oral pan Bcl-2 inhibitor)

Ascenta TherapeuticsMalvern, PA

CLL(see also brain, lung, lymphoma, prostate, stomach)

Ascenta TherapeuticsMalvern, PA

DebiopharmLausanne, Switzerland

AML(see also lymphoma)

www.debiopharm.com

Medicines in Development for Cancer

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Medicines in Development Cancer 201230

LEUKEMIA

Product Name Sponsor Indication Development Status

(CDK inhibitor)Astex PharmaceuticalsDublin, CA

CLL(see also lymphoma, multiple myeloma, solid tumors)

AT9283(aurora/Jak2 inhibitor)(Orphan Drug)

Astex PharmaceuticalsDublin, CA

AML(see also lymphoma, multiple myeloma, solid tumors)

AVL-292(Btk inhibitor)

CelgeneSummit, NJ

second-line CLL (combination therapy) (908) 673-9000

AZD1208(Pim kinase inhibitor)

AstraZenecaWilmington, DE

AML(800) 236-9933

bafetinib(Orphan Drug)

CytRx Los Angeles, CA

second-line CLL (see also brain, prostate)--------------------------------------------------ALL, CML

-------------------------------------------

Bcl-2 inhibitor(ABT-199/GDC-0199)

Abbott LaboratoriesAbbott Park, IL

GenentechSouth San Francisco, CA

CLL(see also lymphoma)

belinostat Spectrum PharmaceuticalsHenderson, NV

AML(see also colorectal, liver, lung, lymphoma, ovarian, other)

(aurora kinase B inhibitor) PharmaceuticalsAML(see also solid tumors)

PharmaceuticalsCLL

bosutinibNew York, NY

previously treated CML application submitted

cenersen(Orphan Drug)

EleosOmaha, NE

AML

Ceplene®

histamine dihydrochloride injection(Orphan Drug)

EpiCept AML application submitted

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 31

LEUKEMIA

Product Name Sponsor Indication Development Status

CLL immunotherapeutic vaccine MaxCyteGaithersburg, MD

CLL

Clolar®

clofarabine injection (Orphan Drug)

GenzymeCambridge, MA

AML (adults)

CNDO-109(tumor activated NK cells)

Coronado BiosciencesBurlington, MA

AML(781) 238-6621

(cytarabine/daunorubicin)(Orphan Drug)

Celator PharmaceuticalsPrinceton, NJ

AML

CT-011 CureTechYavne, Israel

second-line AML (combination therapy)(see also colorectal, lymphoma)

www.curetechbio.com

Seoul, South Korea

AML

Dacogen®

decitabineEisaiWoodcliff Lake, NJ

AML

--------------------------------------------------pediatric AML

application submitted

-------------------------------------------

danusertib Nerviano Medical SciencesNerviano, Italy

CMLwww.nervianoms.com

DCC-2036 Deciphera PharmaceuticalsLawrence, KS

ALL, CML

--------------------------------------------------AML

-------------------------------------------

GenentechSouth San Francisco, CA

CLL(see also lymphoma)

DCDT-2980S GenentechSouth San Francisco, CA

recurrent CLL(see also lymphoma)

Elacyt™elacytarabine(Orphan Drug)

Clavis PharmaOslo, Norway

late-stage AML(Fast Track)--------------------------------------------------early-stage AML

www.clavispharma.com-------------------------------------------

www.clavispharma.com

Medicines in Development for Cancer

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Medicines in Development Cancer 201232

LEUKEMIA

Product Name Sponsor Indication Development Status

elesclomol Synta PharmaceuticalsLexington, MA

AML(see also lung, ovarian)

entinostat Syndax PharmaceuticalsWaltham, MA

(see also breast, colorectal, kidney, lung, lymphoma)

epratuzumab(Orphan Drug) Morris Plains, NJ

UCBAtlanta, GA

ALL in children (combination therapy)(see also lymphoma)

forodesine(Orphan Drug)

BioCryst PharmaceuticalsDurham, NC

CLL(see also lymphoma)

ganetespib (Hsp90i)

Synta PharmaceuticalsLexington, MA

ALL, AML, CML(see also breast, colorectal, liver, lung, multiple myeloma, pancreatic, prostate, skin, stomach)--------------------------------------------------myelodysplastic syndromes

-------------------------------------------

GNKG-168 CLLwww.sbibiotech.jp

GRNVAC1(dendritic cell vaccine)

Argos TherapeuticsDurham, NC

GeronMenlo Park, CA

AML(see also prostate)

GS-1101 Gilead SciencesFoster City, CA

second-line CLL (see also lymphoma)

GSK2110183(protein kinase B inhibitor)

GlaxoSmithKline (see also multiple myeloma)

immunotherapeutic)

GlaxoSmithKline AML

GVAX® Leukemia

cancer vaccine(Orphan Drug)

BioSante PharmaceuticalsLincolnshire, IL

AML, CML

Actinium PharmaceuticalsNewark, NJ

AML

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 33

LEUKEMIA

Product Name Sponsor Indication Development Status

(lintuzumab Bi-213)Actinium PharmaceuticalsNewark, NJ

AML

(lintuzumab-gelonin conjugate)Targa TherapeuticsSan Diego, CA

AML, CML, myelodysplasticsyndromes

ibrutinib Janssen BiotechHorsham, PA

PharmacyclicsSunnyvale, CA

CLL(see also lymphoma, multiple myeloma)

imatinib sublingual Kedem PharmaceuticalsMesa, AZ

CML in clinical trials

imetelstat GeronMenlo Park, CA

CLL(see also breast, lung, multiple myeloma)

Imprime PGG® BiotheraEagan, MN

CLL(see also colorectal, lung, skin)

CytRxLos Angeles, CA

AML, myelodysplastic syndromes(see also solid tumors)

inotuzumab ozogamicinNew York, NY

ALL(see also lymphoma)

(recombinant immunotherapeutic vaccine)

MemgenSan Diego, CA

CLL (monotherapy)(see also lymphoma)--------------------------------------------------refractory metastatic CLL (combination therapy)

-------------------------------------------

(quisinostat)Johnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ

myelodysplastic syndromes, metastatic leukemia(see also lymphoma)

JVRS-100(lipid-DNA complex vaccine)

Colby PharmaceuticalSan Jose, CA

KX2-391 Kinex PharmaceuticalsBuffalo, NY

AML in the elderly(see also prostate) (716) 898-8626

Medicines in Development for Cancer

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Medicines in Development Cancer 201234

LEUKEMIA

Product Name Sponsor Indication Development Status

(panobinostat)Novartis PharmaceuticalsEast Hanover, NJ

ALL, AML, myelodysplastic syndromes(see also kidney, multiple myeloma, prostate, solid tumors)

(888) 669-6682

(erismodegib)Novartis PharmaceuticalsEast Hanover, NJ

CML (combination therapy)(see also pancreatic, solid tumors, skin)

(888) 669-6682

lestaurtinib(Orphan Drug)

CephalonFrazer, PA

AML

leukemia DNA vaccineBlue Bell, PA

University of SouthamptonSouthampton, United Kingdom

AML, CML

(activated T-cells)LentigenGaithersburg, MD

University of PennsylvaniaPhiladelphia, PA

ALL, B-cell prolymphocytic leukemia, CLL(see also lymphoma)

(Orphan Drug)

Lorus Therapeutics AML (combination therapy)(see also breast, colorectal, kidney, prostate)--------------------------------------------------CML, myelodysplastic syndromes

-------------------------------------------

lurbinectedin PharmaMarMadrid, Spain

(see also solid tumors)www.pharmamar.com

Marqibo®

vincristine liposomal(Orphan Drug)

Talon TherapeuticsSan Mateo, CA

relapsed or refractory Philadelphia chromosome-negative ALL (Fast Track)(see also lymphoma, skin, other)--------------------------------------------------ALL in the elderly (Fast Track)

application submitted

-------------------------------------------

milatuzumabMorris Plains, NJ

CLL (monotherapy)(see also lymphoma, multiple myeloma)

(dinaciclib)(Orphan Drug)

MerckWhitehouse Station, NJ

CLL(see also lymphoma) (800) 672-6372

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 35

LEUKEMIA

Product Name Sponsor Indication Development Status

MerckWhitehouse Station, NJ

AML(see also solid tumors) (800) 672-6372

mocetinostat(MGCD0103, HDAC inhibitor)

MethylGeneMontreal, Canada

CLL(see also lymphoma, solid tumors)

Mozobil®

plerixaforGenzymeCambridge, MA

AML

navitoclax(ABT-263)

Abbott LaboratoriesAbbott Park, IL (see also lung, lymphoma)

--------------------------------------------------CLL, lymphoid leukemia

-------------------------------------------

Nexavar®

sorafenibBayer HealthCare PharmaceuticalsWayne, NJ

AML, myelodysplastic syndromes(see also breast, colorectal, head/neck, kidney, liver, lung, multiple myeloma, ovarian, other)

obatoclax(Orphan Drug)

CephalonFrazer, PA

CLL(see also lung, lymphoma, multiple myeloma)

obinutuzumabWeston, MA

GenentechSouth San Francisco, CA

(see also lymphoma)

Omapro™omacetaxine(Orphan Drug)

CephalonFrazer, PA

second-line CML(see also solid tumors)--------------------------------------------------AML, myelodysplastic syndromes

application submitted

-------------------------------------------

Onconova TherapeuticsNewtown, PA

ALL(see also lymphoma)

oral azacitidine(Orphan Drug)

CelgeneSummit, NJ

myelodysplastic syndromes(Fast Track) (see also lung, lymphoma, solid tumors)--------------------------------------------------AML, CML

(908) 673-9000

-------------------------------------------

(908) 673-9000

Medicines in Development for Cancer

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Medicines in Development Cancer 201236

LEUKEMIA

Product Name Sponsor Indication Development Status

oral clofaribine GenzymeCambridge, MA

myelodysplastic syndromes

(Orphan Drug)

TdT-positive leukemia(210) 677-6000

OXiGENESouth San Francisco, CA

AML, myelodysplastic syndromes

perifosine AEterna ZentarisBasking Ridge, NJ

refractory metastatic CLL(see also brain, colorectal, kidney, lung, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach)

(midostaurin)Novartis PharmaceuticalsEast Hanover, NJ

AML(888) 669-6682

PLX3397(CSF-1R kinase inhibitor)

PlexxikonBerkeley, CA

recurrent or refractory AML(see also brain, lymphoma, solid tumors)

ponatinib(Orphan Drug) Cambridge, MA

Philadelphia-positive ALL, CML

--------------------------------------------------AML

-------------------------------------------

ProactaLa Jolla, CA

AML

Revlimid®

lenalidomide(Orphan Drug)

CelgeneSummit, NJ

CLL, myelodysplastic syndromes(see also lymphoma) (908) 673-9000

rigosertib(Orphan Drug)

Onconova TherapeuticsNewtown, PA

myelodysplastic syndromes (intravenous)(see also lymphoma, ovarian, pancreatic)--------------------------------------------------CLL

--------------------------------------------------AML

--------------------------------------------------myelodysplastic syndromes (oral)

-------------------------------------------

-------------------------------------------

-------------------------------------------

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 37

LEUKEMIA

Product Name Sponsor Indication Development Status

sapacitabine (CYC682)(Orphan Drug)

Cyclacel PharmaceuticalsBerkeley Heights, NJ (see also lung, solid tumors)

--------------------------------------------------CLL (combination therapy),myelodysplastic syndromes

-------------------------------------------

SB989 (pracinostat) Oakland, CA

myelodysplastic syndromes(see also solid tumors, other)

(pacritinib) Oakland, CA

myelodysplastic syndromes

--------------------------------------------------myeloid leukemia

-------------------------------------------

SF1126(Orphan Drug)

Semafore PharmaceuticalsIndianapolis, IN

CLL(see also multiple myeloma, solid tumors)

(DNMT inhibitor)Astex PharmaceuticalsDublin, CA

AML, myelodysplastic syndromes

(recombinant fusion protein)(Orphan Drug)

Stemline TherapeuticsNew York, NY

AML, myelodysplastic syndromes

tamibarotene(Orphan Drug)

CytRxLos Angeles, CA

acute promyelocytic leukemia (APL) (Fast Track)(see also lung)--------------------------------------------------APL (combination therapy)

-------------------------------------------

Tarceva®

erlotinibGenentechSouth San Francisco, CA

Farmingdale, NY

myelodysplastic syndromes(see also brain, breast, head/neck, liver, lung, other) (631) 962-0600

Tasigna®

nilotinib(Orphan Drug)

Novartis PharmaceuticalsEast Hanover, NJ

CML (adolescents and children), ALL (adolescents and children)(see also skin, stomach)

(888) 669-6682

Temodar®

temozolomideMerckWhitehouse Station, NJ

AML(see also lung) (800) 672-6372

TH-302 Threshold PharmaceuticalsSouth San Francisco, CA

(see also brain, multiple myeloma, pancreatic, sarcoma)

thiarabine Access Pharmaceuticals (see also lymphoma)

Medicines in Development for Cancer

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Medicines in Development Cancer 201238

LEUKEMIA

Product Name Sponsor Indication Development Status

TL-32711(birinapant)

TetraLogic PharmaceuticalsMalvern, PA

AML(see also solid tumors) (610) 889-9900

tosedostat(Orphan Drug)

Chroma TherapeuticsOxon, United Kingdom

AMLwww.chromatherapeutics.com

trametinib GlaxoSmithKline relapsed or refractory leukemia(see also brain, lung, lymphoma, multiple myeloma, pancreatic, skin)

Treanda®

bendamustineCephalonFrazer, PA

ALL in children, AML in children(see also lymphoma, multiple myeloma)

treosulfan MedacWedel, Germany

ALL, AML, myelodysplastic syndromes www.medac.de

TRU-016(humanized anti-CD37 therapeutic)

Emergent BioSolutionsRockville, MD

CLL(see also lymphoma)

Velcade®

bortezomibMillennium PharmaceuticalsCambridge, MA

second-line T-cell prolymphocytic leukemia (see also lymphoma, other, cancer-related)

veltuzumab(Orphan Drug) Morris Plains, NJ

CLL(see also lymphoma)

Vidaza®

azacitidine(Orphan Drug)

CelgeneSummit, NJ

AML in the elderly(see also lymphoma) (908) 673-9000

vosaroxin(Orphan Drug)

Sunesis PharmaceuticalsSouth San Francisco, CA

second-line AML(Fast Track)(see also ovarian)--------------------------------------------------AML in the elderly

-------------------------------------------

XmAb® 5574

(MOR208, anti-CD19 mAb)MorphoSysPlanegg, Germany

XencorMonrovia, CA

recurrent CLLwww.morphosys.com

Zolinza®

vorinostatMerckWhitehouse Station, NJ

AML, myelodysplastic syndromes(see also breast, lung, lymphoma, multiple myeloma, other)

(800) 672-6273

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 39

LIVER CANCER

Product Name Sponsor Indication Development Status

ALN-VSP Alnylam PharmaceuticalsCambridge, MA

bavituximab Peregrine Pharmaceuticals (see also lung, pancreatic)

BAY 86-9766(MEK inhibitor)

Ardea BiosciencesSan Diego, CA

Bayer HealthCare PharmaceuticalsWayne, NJ

(combination therapy)(see also pancreatic)

belinostat Spectrum PharmaceuticalsHenderson, NV

inoperable/unresectable liver cancer(see also colorectal, leukemia, lung, lymphoma, ovarian, other)

Cambridge, MA

(see also lung)(617) 679-2000

brivanib(VEGFR/FGFR kinase inhibitor)

Bristol-Myers SquibbPrinceton, NJ liver cancer (TACE)

(see also colorectal, sarcoma)

cixutumumab Eli LillyIndianapolis, IN

Bridgewater, NJ

(see also lung)

darinaparsinNew York, NY

(see also lymphoma, multiple myeloma, solid tumors)

DC Bead®

doxorubicin-eluting beadsBayer HealthCare PharmaceuticalsWayne, NJ

BiocompatiblesSurrey, United Kingdom

EisaiWoodcliff Lake, NJ

(see also brain, head/neck, skin, solid tumors, stomach)

foretinib(GSK1363089)

GlaxoSmithKline (see also head/neck, kidney, lung)

ganetespib (Hsp90i)

Synta PharmaceuticalsLexington, MA

(see also breast, colorectal, leukemia, lung, multiple myeloma, pancreatic, prostate, skin, stomach)

Inlyta®

axitinib New York, NY

(see also kidney, other)

irinotecan eluting beadsSurrey, United Kingdom

liver metastases from colorectal cancer www.biocompatibles.com

Medicines in Development for Cancer

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Medicines in Development Cancer 201240

LIVER CANCER

Product Name Sponsor Indication Development Status

(pexastimogene devacirepvec)(Orphan Drug)

Jennerex BiotherapeuticsSan Francisco, CA

(see also colorectal)

lansoprazole (Orphan Drug)

Apricus BiosciencesSan Diego, CA

linifanib Abbott LaboratoriesAbbott Park, IL (see also breast, colorectal, kidney,

lung)

mapatumumab Human Genome SciencesRockville, MD

liver cancer (combination therapy)(see also lung, multiple myeloma)

MB07133(HepDirect HepB inhibitor)

Ligand PharmaceuticalsLa Jolla, CA

inoperable/unresectable liver cancer

melphalan drug delivery system Delcath SystemsNew York, NY

inoperable/unresectable liver cancer application submitted

Progen PharmaceuticalsQueensland, Australia

liver cancer (Fast Track)(see also skin) www.progen.com.au

Nexavar®

sorafenib(Orphan Drug)

Bayer HealthCare PharmaceuticalsWayne, NJ

heptocellular carcinoma (adjuvant therapy)(see also breast, colorectal, head/neck, kidney, leukemia, lung, multiple myeloma, ovarian, other)

NV-1020 CatherexPhiladelphia, PA

OBP-301 Oncolys Biopharma (see also breast, head/neck, lung)www.oncolys.com

PEG arginine deiminase Polaris PharmaceuticalsSan Diego, CA

hepatocellular carcinoma(see also prostate, skin, other)

PHY906 PhytoCeutica (see also colorectal, pancreatic, cancer-related)

PV-10(rose bengal sodium)(Orphan Drug)

Provectus Pharmaceuticals liver cancer, liver metastases(see also skin)

RG7686 RocheNutley, NJ

metastatic liver cancer(combination therapy)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 41

LIVER CANCER

Product Name Sponsor Indication Development Status

Tarceva®

erlotinibGenentechSouth San Francisco, CA

Farmingdale, NY

cancer (combination therapy)(see also brain, breast, head/neck, leukemia, lung, other)--------------------------------------------------second-line liver cancer (combination therapy)

(631) 962-0600

-------------------------------------------

(631) 962-0600

TGF-ß R1 inhibitor Eli LillyIndianapolis, IN

(see also brain)

ThermoDox®

doxorubicin liposomal(Orphan Drug)

CelsionLawrenceville, NJ cancer (Fast Track)

(see also breast, colorectal)(609) 896-9100

tigatuzumab Daiichi SankyoParsippany, NJ

(see also breast, colorectal, lymphoma, ovarian, pancreatic)

tivantinib (ARQ 197) ArQuleWoburn, MA

Daiichi SankyoParsippany, NJ

second-line liver cancer (see also colorectal, kidney, lung, pancreatic, sarcoma, other)--------------------------------------------------liver cancer (combination therapy)

------------------------------------------

trebananib (AMG386)

Amgen (see also breast, colorectal, kidney, ovarian, stomach, other)

Xeloda®

capecitabineGenentechSouth San Francisco, CA

biliary cancer (combination therapy)(see also brain, colorectal, stomach)

Zadaxin®

thymalfasin alfa 1(Orphan Drug)

SciClone PharmaceuticalsFoster City, CA

(see also skin)

Medicines in Development for Cancer

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Medicines in Development Cancer 201242

LUNG CANCER

Product Name Sponsor Indication Development Status

Abraxane®

albumin-bound paclitaxelCelgeneSummit, NJ (NSCLC)

(see also bladder, breast, ovarian, pancreatic, skin)

application submitted(908) 673-9000

ABT-888 (veliparib)(PARP inhibitor)

Abbott LaboratoriesAbbott Park, IL

NSCLC(see also brain, breast, colorectal, lymphoma, ovarian, prostate, skin, other)

(pan-HER inhibitor)Ambit BiosciencesSan Diego, CA

NCSLC(see also brain, breast)

Actimid®

pomalidomideCelgeneSummit, NJ

small-cell lung cancer (SCLC)(see also lymphoma, multiple myeloma, pancreatic)

(908) 673-9000

afatinibPharmaceuticals (see also brain, breast, head/neck)

--------------------------------------------------second-line NSCLC (Fast Track)

-------------------------------------------

Alimta®

pemetrexedEli LillyIndianapolis, IN

AMG888/U3-1287(anti-HER3 antibody)

Amgen

Daiichi SankyoParsippany, NJ

NSCLC

amrubicin(Orphan Drug)

CelgeneSummit, NJ

SCLC (Fast Track)(see also breast)--------------------------------------------------

(908) 673-9000-------------------------------------------

(908) 673-9000

amuvatinib Astex PharmaceuticalsDublin, CA

SCLC (combination therapy)(see also lymphoma)

anti-PD1 Bristol-Myers SquibbPrinceton, NJ

(see also kidney, skin)

AP26113Cambridge, MA

NSCLC

apricoxib(TG01)

Tragara PharmaceuticalsSan Diego, CA

second-line NSCLC (combination therapy)(see also pancreatic)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 43

LUNG CANCER

Product Name Sponsor Indication Development Status

astuprotimut-R

cancer immunotherapeutic)

GlaxoSmithKline adjuvant NSCLC (see also skin)

AT-101(oral pan Bcl-2 inhibitor)

Ascenta TherapeuticsMalvern, PA

NSCLC (combination therapy), SCLC (combination therapy) (see also brain, leukemia, lymphoma, prostate, stomach)

AUY922(Hsp90 inhibitor)

Novartis PharmaceuticalsEast Hanover, NJ

third-line NSCLC(see also breast, colorectal, multiple myeloma, stomach)--------------------------------------------------second-line late-stage NSCLC(combination therapy)

(888) 669-6682

-------------------------------------------

(888) 669-6682

Avastin®

bevacizumabGenentechSouth San Francisco, CA

adjuvant NSCLC (see also brain, breast, colorectal, ovarian, other)

bavituximab Peregrine Pharmaceuticalssecond-line NSCLC(see also liver, pancreatic)

belinostat Spectrum PharmaceuticalsHenderson, NV

mesothelioma(see also colorectal, leukemia, liver, lymphoma, ovarian, other)--------------------------------------------------NSCLC

--------------------------------------------------SCLC

-------------------------------------------

-------------------------------------------

Cambridge, MA

NSCLC(see also liver) (617) 679-2000

BKM120 Novartis PharmaceuticalsEast Hanover, NJ

late-stage NSCLC (see also brain, breast, other) (888) 669-6682

cabozantinib ExelixisSouth San Francisco, CA

NSCLC(see also breast, kidney, ovarian, prostate, other)

(peptide mimetic)CanBasShizouka, Japan

mesothelioma (combination therapy),

therapy)(see also solid tumors)

www.canbas.co.jp

Medicines in Development for Cancer

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Medicines in Development Cancer 201244

LUNG CANCER

Product Name Sponsor Indication Development Status

CC-223(mTOR inhibitor)

CelgeneSummit, NJ

NSCLC(see also lymphoma, multiple myeloma)

(908) 673-9000

CEP-9722(PARP inhibitor)

CephalonFrazer, PA

NSCLC (combination therapy)(see also lymphoma)

Chk1 inhibitor(LY2603618)

Eli LillyIndianapolis, IN

NSCLC(see also pancreatic)

cixutumumab Eli LillyIndianapolis, IN

Bridgewater, NJ

NSCLC(see also liver)

Novelos TherapeuticsMadison, WI

NSCLC (diagnosis)

Novelos TherapeuticsMadison, WI

NSCLC (diagnosis)

CO-1686(EGFR inhibitor)

Clovis OncologyBoulder, CO

second-line NSCLC

custirsen(OGX-001/TV-1011)

OncoGenex PharmaceuticalsBothell, WA

Teva Pharmaceuticals(see also prostate)

dacomitinibNew York, NY

NSCLC(see also solid tumors)

dalotuzumab MerckWhitehouse Station, NJ

recurrent NSCLC (combination therapy)(see also breast, pancreatic, other)

(800) 672-6372

EC20(technetium Tc-99m etarfolatide)

EndocyteWest Lafayette, IN

NSCLC (diagnosis)(see also ovarian) www.endocyte.com

(vintafolide)EndocyteWest Lafayette, IN

MerckWhitehouse Station, NJ

NSCLC(see also ovarian) www.endocyte.com

(800) 672-6372

efatutazone Daiichi SankyoParsippany, NJ

NSCLC(see also colorectal, other)

elesclomol Synta PharmaceuticalsLexington, MA

NSCLC(see also leukemia, ovarian)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 45

LUNG CANCER

Product Name Sponsor Indication Development Status

emepepimut-S EMD SeronoRockland, MA

OncothyreonSeattle, WA

NSCLC (Fast Track)(see also prostate) (800) 283-8088

entinostat Syndax PharmaceuticalsWaltham, MA

NSCLC (combination therapy)(see also breast, colorectal, kidney, leukemia, lymphoma)

(AV-299)AVEO PharmaceuticalsCambridge, MA

NSCLC (combination therapy)(see also solid tumors)

Folotyn®

pralatrexateAllos TherapeuticsWestminster, CO

NSCLC(see also bladder, breast, lymphoma)

foretinib(GSK1363089)

GlaxoSmithKline NSCLC (see also head/neck, kidney, liver)

ganetespib (Hsp90i)

Synta PharmaceuticalsLexington, MA

second-line NSCLC (combination therapy)(see also breast, colorectal, leukemia, liver, multiple myeloma, pancreatic, prostate, skin, stomach)--------------------------------------------------SCLC

-------------------------------------------

ganitumab Amgen(see also breast, colorectal, pancreatic, sarcoma)

(cancer vaccine) Louisville, CO

NSCLC(see also colorectal, pancreatic)

Gleevec®

imatinibNovartis PharmaceuticalsEast Hanover, NJ

NSCLC (combination therapy)(see also prostate, skin, other) (888) 669-6682

(BRaf protein kinase inhibitor)GlaxoSmithKline BRAF mutation-positive disease

NSCLC(see also brain, skin)

Halaven®

eribulinEisaiWoodcliff Lake, NJ

NSCLC(see also prostate, sarcoma)

HS-110(cancer vaccine)

Heat BiologicsChapel Hill, NC

late-stage NSCLC (combination therapy)

Medicines in Development for Cancer

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Medicines in Development Cancer 201246

LUNG CANCER

Product Name Sponsor Indication Development Status

HyperAcute® Lung

lung cancer immunotherapyNewLink GeneticsAmes, IA

metastatic NSCLC

(multi-epitope cancer vaccine)Biotech SynergySan Diego, CA

NSCLC

imetelstat GeronMenlo Park, CA

late-stage NSCLC(see also breast, leukemia, multiple myeloma)

(TLR9 agonist) Cambridge, MA

(see also colorectal, head/neck)

Imprime PGG® BiotheraEagan, MN

NSCLC(see also colorectal, leukemia, skin)

iniparibBridgewater, NJ

squamous NSCLC(see also breast, ovarian)--------------------------------------------------non-squamous NSCLC

-------------------------------------------

Iressa® AstraZenecaWilmington, DE NSCLC (800) 236-9933

RxCarlsbad, CA

late-stage NSCLC (combination therapy)(see also prostate)

(Hdm2 inhibitor)Johnson & Johnson Pharmaceutical Research & DevelopmentRaritan, NJ

NSCLC(see also prostate, solid tumors)

Karenitecin® BioNumerik Pharmaceuticals NSCLC(see also ovarian, solid tumors)

KD019 Kadmon PharmaceuticalsWarrendale, PA

late-stage NSCLC

KD032(ras/mTOR inhibitor)

Kadmon PharmaceuticalsWarrendale, PA

NSCLC(see also pancreatic)

linifanib Abbott LaboratoriesAbbott Park, IL

NSCLC(see also breast, colorectal, kidney, liver)

litronesib Eli LillyIndianapolis, IN

NSCLC(see also breast)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 47

LUNG CANCER

Product Name Sponsor Indication Development Status

lorvotuzumab mertansine

(Orphan Drug)

Waltham, MA

SCLC(see also multiple myeloma)

Lucanix®

belagenpumatucel-LNovaRxSan Diego, CA

NSCLC (Fast Track)(see also brain)

mapatumumab Human Genome SciencesRockville, MD

NSCLC (combination therapy)(see also liver, multiple myeloma)

(anti-PDGFR-alpha mAb)AstraZenecaWilmington, DE

Gaithersburg, MD

NSCLC(see also brain) (800) 236-9933

(301) 398-0000

(multi-kinase inhibitor)MethylGeneMontreal, Canada

NSCLC (combination therapy)

MORAb-003(farletuzumab)

EisaiWoodcliff Lake, NJ

NSCLC(see also ovarian)

MORAb-009(amatuximab)

EisaiWoodcliff Lake, NJ

mesothelioma

motesanib Amgen NSCLC(see also breast, colorectal, other)

naptumomab estafenatox Active BiotechLund, Sweden

NSCLC (Fast Track)(see also kidney, pancreatic) www.activebiotech.com

navitoclax(ABT-263)

Abbott LaboratoriesAbbott Park, IL

NSCLC, SCLC(see also leukemia, lymphoma)

necitumumab Bristol-Myers SquibbPrinceton, NJ

Eli LillyIndianapolis, IN

Bridgewater, NJ

NSCLC

Nexavar®

sorafenibBayer HealthCare PharmaceuticalsWayne, NJ

NSCLC(see also breast, colorectal, head/neck, kidney, leukemia, liver, multiple myeloma, ovarian, other)

Medicines in Development for Cancer

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Medicines in Development Cancer 201248

LUNG CANCER

Product Name Sponsor Indication Development Status

NGR-hTNF(Orphan Drug)

MolMedMilan, Italy

second-line mesothelioma www.molmed.com

NK-012 Nippon Kayaku SCLC(see also breast) www.nipponkayaku.co.jp

NTX-010 NeotropixMalvern, PA

SCLC(see also other) www.neotropix.com

obatoclax CephalonFrazer, PA (see also leukemia, lymphoma,

multiple myeloma)

OBP-301 Oncolys Biopharma mesothelioma(see also breast, head/neck, liver) www.oncolys.com

OncoGenex PharmaceuticalsBothell, WA

NSCLC(see also breast, ovarian)

ombrabulin (AVE8062) Bridgewater, NJ (see also ovarian, sarcoma)

onartuzumab GenentechSouth San Francisco, CA

metastatic NSCLC(see also breast, colorectal)

Oncoprex™(TUSC2/FUS1 gene therapy)

Genprex NSCLC

Opaxio™paclitaxel poliglumex

Cell TherapeuticsSeattle, WA

NSCLC(see also brain, ovarian, stomach, other)

oral azacitidine CelgeneSummit, NJ

NSCLC(see also leukemia, lymphoma, solid tumors)

(908) 673-9000

inhibitor)Farmingdale, NY

NSCLC(see also ovarian, other) (631) 962-0600

Bryan OncorSomerville, MA

NSCLC, SCLC

palifosfamideNew York, NY

SCLC(see also sarcoma, solid tumors)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 49

LUNG CANCER

Product Name Sponsor Indication Development Status

pegdinetanib (VEGFR-2 adnectin)

Bristol-Myers SquibbPrinceton, NJ

NSCLC

perifosine AEterna ZentarisBasking Ridge, NJ

NSCLC(see also brain, colorectal, kidney, leukemia, lymphoma, multiple myeloma, sarcoma, solid tumors, stomach)

picoplatin(Orphan Drug)

Ponaird PharmaceuticalsSeattle, WA

second-line SCLC(Fast Track)(see also colorectal, ovarian, prostate)

(206) 281-7001

plinabulin Nereus PharmaceuticalsSan Diego, CA

NSCLC

immunotherapeutic (recombinant)

GlaxoSmithKline NSCLC(see also skin)

PT107(allogeneic tumor cell vaccine)

Pique TherapeuticsDurham, NC

NSCLC

PX-866 OncothyreonSeattle, WA

NSCLC (combination therapy)(see also brain, head/neck, prostate) (206) 801-2100

ranpirnase Tamir BiotechnologyMonmouth Junction, NJ

NSCLC(732) 823-1003

regorafenib Bayer HealthCare PharmaceuticalsWayne, NJ

NSCLC(see also colorectal, kidney, solid tumors, stomach)

Reolysin®

reovirusOncolytics BiotechCalgary, Canada

NSCLC (combination therapy)(see also brain, colorectal, head/neck, ovarian, pancreatic, sarcoma, skin, solid tumors)

retaspimycinCambridge, MA

NSCLC

(EGFL7 inhibitor)GenentechSouth San Francisco, CA

NSCLC(see also colorectal)

Medicines in Development for Cancer

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Medicines in Development Cancer 201250

LUNG CANCER

Product Name Sponsor Indication Development Status

(antibody drug conjugate)GenentechSouth San Francisco, CA

NSCLC(see also ovarian)

ridaforolimusCambridge, MA

MerckWhitehouse Station, NJ

NSCLC(see also breast, kidney, prostate, sarcoma, other)

(800) 672-6372

sapacitabine (CYC682)

Cyclacel PharmaceuticalsBerkeley Heights, NJ

NSCLC(see also leukemia, solid tumors)

(anti-ErbB3 mAb)Merrimack PharmaceuticalsCambridge, MA

Bridgewater, NJ

NSCLC(see also breast, ovarian)

talactoferrin alfa (oral)(Orphan Drug)

AgennixPrinceton, NJ

NSCLC(Fast Track)

tamibarotene CytRxLos Angeles, CA

NSCLC(see also leukemia)

Tarceva®

erlotinibGenentechSouth San Francisco, CA

Farmingdale, NY

adjuvant NSCLC (see also brain, breast, head/neck, leukemia, liver, other) (631) 962-0600

Tavocept®

dimesnaBioNumerik Pharmaceuticals (see also cancer-related)

Tc-99m ethylenedicysteine glucosamine(EC-G)

Cell PointCentennial, CO

NSCLC (diagnosis)(303) 689-9693

Telcyta™canfosfamide

TelikPalo Alto, CA

third-line NSCLC (see also lymphoma, ovarian)

Temodar®

temozolomideMerckWhitehouse Station, NJ

SCLC(see also leukemia) (800) 672-6372

tivantinib (ARQ 197)

ArQuleWoburn, MA

Daiichi SankyoParsippany, NJ

NSCLC(see also colorectal, kidney, liver, pancreatic, sarcoma, other)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 51

LUNG CANCER

Product Name Sponsor Indication Development Status

topotecan liposomes injection Talon TherapeuticsSan Mateo, CA

SCLC(see also ovarian)

trametinib GlaxoSmithKline second-line NSCLC (see also leukemia, lymphoma, multiple myeloma, pancreatic, skin)

Vargatef™intedanib Pharmaceuticals

second-line late-stage NSCLC (combination therapy)(see also ovarian)

veglin (VEGF antisense)

VasGene TherapeuticsLos Angeles, CA

mesothelioma(see also kidney, skin) (323) 221-7818

volociximab Abbott LaboratoriesAbbott Park, IL

Weston, MA

NSCLC

Xalkori®

crizotinib(Orphan Drug)

New York, NY second-line ALK-positive NSCLC(see also solid tumors)--------------------------------------------------NSCLC (combination therapy)

-------------------------------------------

YERVOY®

ipilimumabBristol-Myers SquibbPrinceton, NJ

NSCLC, SCLC(see also prostate, skin)

in clinical trials

Zolinza®

vorinostat(Orphan Drug)

MerckWhitehouse Station, NJ

mesothelioma(see also breast, leukemia, lymphoma, multiple myeloma, other)

(800) 672-6273

Zybrestat™fosbretabulin

OXiGENESouth San Francisco, CA (see also ovarian)

Medicines in Development for Cancer

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Medicines in Development Cancer 201252

LYMPHOMA

Product Name Sponsor Indication Development Status

abexinostat(HDAC inhibitor)

PharmacyclicsSunnyvale, CA

lymphoma(see also sarcoma)

ABT-888 (veliparib)(PARP inhibitor)

Abbott LaboratoriesAbbott Park, IL

(see also brain, breast, colorectal, lung, ovarian, prostate, skin, other)

Actimid®

pomalidomideCelgeneSummit, NJ (see also lung, multiple myeloma,

pancreatic)(908) 673-9000

Adcetris™brentuximab vedotin

Millennium PharmaceuticalsCambridge, MA

Seattle GeneticsBothell, WA

post-transplant Hodgkin’s lymphoma relapse prevention(see also leukemia)--------------------------------------------------relapsed/refractory CD30-positive non-Hodgkin’s lymphoma, relapsed/refractory anaplastic large-cell lymphoma--------------------------------------------------

lymphoma

-------------------------------------------

-------------------------------------------

Adcetris™ Companion Diagnostic

brentuximab vedotin companion diagnostic

Millennium PharmaceuticalsCambridge, MA

Seattle GeneticsBothell, WA

Ventana Medical Systems

cutaneous T-cell lymphoma (diagnosis), T-cell lymphoma (diagnosis)

in clinical trials(617) 679-7000

Aegera TherapeuticsMontreal, Canada

B-cell lymphoma(see also leukemia)

AEZS-112 AEterna Zentaris Basking Ridge, NJ

(see also solid tumors)

®

everolimusNovartis PharmaceuticalsEast Hanover, NJ

mantle cell lymphoma(see also breast, kidney) (888) 669-6682

AFM13Heidelberg, Germany

second-line Hodgkin’s disease

Alocrest™vinorelbine liposomal

Talon TherapeuticsSan Mateo, CA

non-Hodgkin’s lymphoma(see also solid tumors)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 53

LYMPHOMA

Product Name Sponsor Indication Development Status

AME-133v (ocaratuzumab)

non-Hodgkin’s lymphoma

Amplimexon®

imexonAmpliMed second-line non-Hodgkin’s lymphoma

amuvatinib Astex PharmaceuticalsDublin, OH

(see also lung)

anti-CD22 mAb Abiogen PharmaPisa, Italy

B-cell lymphomawww.abiogen.com

Aplidin®

plitidepsinPharmaMarMadrid, Spain

(see also multiple myeloma, solid tumors) www.pharmamar.com

AR-12 Arno TherapeuticsFlemington, NJ

(see also solid tumors)(862) 703-7170

Arno TherapeuticsFlemington, NJ

(see also leukemia, multiple myeloma) (862) 703-7170

Arranon®

nelarabine(Orphan Drug)

GlaxoSmithKline(see also leukemia)--------------------------------------------------second-line T-cell lymphoma

(888) 669-6682-------------------------------------------

(888) 669-6682

Arzerra®

ofatumumabGlaxoSmithKline second-line diffuse large B-cell

lymphoma, second-line follicular lymphoma(see also leukemia)-------------------------------------------------- -------------------------------------------

ASP3026 Astellas Pharma US late-stage B-cell lymphoma(see also solid tumors)

AT-101(oral pan Bcl-2 inhibitor)

Ascenta TherapeuticsMalvern, PA

non-Hodgkin’s lymphoma(see also brain, leukemia, lung, prostate, stomach)

Ascenta TherapeuticsMalvern, PA

DebiopharmLausanne, Switzerland

lymphoma (see also leukemia)

www.debiopharm.com

Medicines in Development for Cancer

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Medicines in Development Cancer 201254

LYMPHOMA

Product Name Sponsor Indication Development Status

(CDK inhibitor)Astex PharmaceuticalsDublin, CA

mantle cell lymphoma(see also leukemia, multiple myeloma, solid tumors)

AT9283(aurora/Jak2 inhibitor)

Astex PharmaceuticalsDublin, CA

non-Hodgkin’s lymphoma(see also leukemia, multiple myeloma, solid tumors)

autologous cancer vaccineDusseldorf, Germany

Stellar BiotechnologiesPort Hueneme, CA

follicular lymphoma (prevention of relapse)

AVL-292(Btk inhibitor)

CelgeneSummit, NJ

second-line non-Hodgkin’s - (908) 673-9000

Bcl-2 inhibitor(ABT-199/GDC-0199)

Abbott LaboratoriesAbbott Park, IL

GenentechSouth San Francisco, CA

non-Hodgkin’s lymphoma(see also leukemia)

belinostat(Orphan Drug)

Spectrum PharmaceuticalsHenderson, NV

peripheral T-cell lymphoma (PTCL) (Fast Track)(see also colorectal, leukemia, liver, lung, ovarian, other)

Bexxar®

tositumomab and iodine GlaxoSmithKline mantle cell lymphoma

(combination therapy)

BiovaxID®

B-cell lymphoma vaccine(personalized lymphoma vaccine)

indolent follicular lymphoma (Fast Track)--------------------------------------------------mantle cell lymphoma

-------------------------------------------

(kinase inhibitor)CelgeneSummit, NJ

non-Hodgkin’s lymphoma(see also multiple myeloma, solid tumors)

(908) 673-9000

CC-122 CelgeneSummit, NJ

non-Hodgkin’s lymphoma(see also multiple myeloma, solid tumors)

(908) 673-9000

CC-223(mTOR inhibitor)

CelgeneSummit, NJ

non-Hodgkin’s lymphoma(see also lung, multiple myeloma) (908) 673-9000

CEP-9722(PARP inhibitor)

CephalonFrazer, PA

mantle cell lymphoma (combination therapy)(see also lung)

Medicines in Development for Cancer

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LYMPHOMA

Product Name Sponsor Indication Development Status

Clearazide™mechlorethamine gel(Orphan Drug)

Ceptaris TherapeuticsMalvern, PA

cutaneous T-cell lymphoma(Fast Track)

application submitted

CT-011 CureTechYavne, Israel

diffuse large B-cell lymphoma, second-line follicular lymphoma (combination therapy)(see also colorectal, leukemia)

www.curetechbio.com

darinaparsin

(Orphan Drug)

New York, NY

second-line peripheral T-cell lymphoma(see also liver, multiple myeloma, solid tumors)--------------------------------------------------

(combination therapy), non-Hodgkin’s lymphoma

-------------------------------------------

GenentechSouth San Francisco, CA

non-Hodgkin’s lymphoma(see also leukemia)

DCDT-2980S GenentechSouth San Francisco, CA

recurrent non-Hodgkin’s lymphoma(see also leukemia)

Alopexx OncologyWaltham, MA

non-Hodgkin’s lymphoma

entinostat Syndax PharmaceuticalsWaltham, MA

Hodgkin’s disease(see also breast, colorectal, kidney, leukemia, lung)

enzastaurin Eli LillyIndianapolis, IN

diffuse large B-cell lymphoma

epratuzumab(Orphan Drug) Morris Plains, NJ

UCBAtlanta, GA

diffuse large B-cell lymphoma (combination therapy), follicular lymphoma (combination therapy)(see also leukemia)

epratuzumab Y-90Morris Plains, NJ

diffuse large B-cell lymphoma

--------------------------------------------------recurrent non-Hodgkin’s lymphoma

-------------------------------------------

Medicines in Development for Cancer

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Medicines in Development Cancer 201256

LYMPHOMA

Product Name Sponsor Indication Development Status

EZN-2968 Enzon PharmaceuticalsPiscataway, NJ

(see also solid tumors)

Folotyn®

pralatrexate(Orphan Drug)

Allos TherapeuticsWestminster, CO

peripheral T-cell lymphoma

(see also bladder, breast, lung)--------------------------------------------------B-cell non-Hodgkin’s lymphoma, lymphoma (combination therapy)--------------------------------------------------cutaneous T-cell lymphoma

-------------------------------------------

-------------------------------------------

forodesine(Orphan Drug)

BioCryst PharmaceuticalsDurham, NC

cutaneous T-cell lymphoma(see also leukemia)

galiximabCambridge, MA

non-Hodgkin’s lymphoma(combination therapy)--------------------------------------------------

(monotherapy)

(617) 679-2000-------------------------------------------

(617) 679-2000

(small molecule)GenentechSouth San Francisco, CA

non-Hodgkin’s lymphoma(see also solid tumors)

(ChK1 inhibitor)GenentechSouth San Francisco, CA

(see also solid tumors)

GenentechSouth San Francisco, CA

(see also solid tumors)

GDC-0917 GenentechSouth San Francisco, CA

(see also solid tumors)

GDC-0980

inhibitor)

GenentechSouth San Francisco, CA

non-Hodgkin’s lymphoma(see also breast, solid tumors)

GS-1101 Gilead SciencesFoster City, CA

indolent non-Hodgkin’s lymphoma(see also leukemia)

(polio-like kinase inhibitor)GlaxoSmithKline non-Hodgkin’s lymphoma

(see also solid tumors)

GSK690693(AKT kinase inhibitor)

GlaxoSmithKline (see also solid tumors)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 57

LYMPHOMA

Product Name Sponsor Indication Development Status

GlaxoSmithKline (see also solid tumors)

(protein kinase B inhibitor)GlaxoSmithKline (see also solid tumors)

iboctadekin GlaxoSmithKline non-Hodgkin’s lymphoma (combination therapy)(see also ovarian)

ibrutinib Janssen BiotechHorsham, PA

PharmacyclicsSunnyvale, CA

diffuse large B-cell lymphoma, mantle cell lymphoma(see also leukemia, multiple myeloma)

Waltham, MA

metastatic non-Hodgkin’s lymphoma

(mTOR inhibitor) La Jolla, CA (see also multiple myeloma, solid tumors)

inotuzumab ozogamicinNew York, NY

aggressive non-Hodgkin’s lymphoma(see also leukemia)--------------------------------------------------diffuse large B-cell lymphoma, indolent non-Hodgkin’s lymphoma

-------------------------------------------

interleukin-12 gene therapy OncoSec MedicalSan Diego, CA

cutaneous T-cell lymphoma(see also skin) www.oncosec.com

MemgenSan Diego, CA

follicular lymphoma, diffuse large cell lymphoma, mantle cell lymphoma, small lymphocytic lymphoma(see also leukemia)

(quisinostat)Johnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ

cutaneous T-cell lymphoma(see also leukemia)

LEE011 Novartis PharmaceuticalsEast Hanover, NJ

(see also solid tumors)(888) 669-6682

(activated T-cells)LentigenGaithersburg, MD

University of PennsylvaniaPhiladelphia, PA

diffuse large B-cell lymphoma, follicular lymphoma, mantle-cell lymphoma(see also leukemia)

Medicines in Development for Cancer

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Medicines in Development Cancer 201258

LYMPHOMA

Product Name Sponsor Indication Development Status

lucatumumab(HDC122)

Novartis PharmaceuticalsEast Hanover, NJ

XOMABerkeley, CA

lymphoma

--------------------------------------------------follicular lymphoma

(888) 669-6682-------------------------------------------

(888) 669-6682

Marqibo®

vincristine liposomalTalon TherapeuticsSan Mateo, CA

non-Hodgkin’s lymphoma(see also leukemia, skin, other)

milatuzumabMorris Plains, NJ

non-Hodgkin’s lymphoma(see also leukemia, multiple myeloma)

(dinaciclib)MerckWhitehouse Station, NJ

mantle cell lymphoma(see also leukemia) (800) 672-6372

MK-8808 MerckWhitehouse Station, NJ

late-stage follicular lymphoma (combination therapy) (800) 672-6372

MLN8237(alisertib)

Millennium PharmaceuticalsCambridge, MA

peripheral T-cell lymphoma (see also solid tumors)

MLN9708(ixazomib)

Millennium PharmaceuticalsCambridge, MA macroglobulinemia

(see also multiple myeloma, solid tumors)

mocetinostat(MGCD0103, HDAC inhibitor)(Orphan Drug)

MethylGeneMontreal, Canada

diffuse large B-cell lymphoma, follicular lymphoma(see also leukemia, solid tumors)

mogamulizumab(Orphan Drug)

Amgen cutaneous T-cell lymphoma, peripheral T-cell lymphoma

navitoclax(ABT-263)

Abbott LaboratoriesAbbott Park, IL

(see also leukemia, lung)

(marizomib)Nereus PharmaceuticalsSan Diego, CA

(see also multiple myeloma, solid tumors)

obatoclax(Orphan Drug)

CephalonFrazer, PA (combination therapy)

(see also leukemia, lung, multiple myeloma)--------------------------------------------------mantle cell lymphoma

-------------------------------------------

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 59

LYMPHOMA

Product Name Sponsor Indication Development Status

obinutuzumabWeston, MA

GenentechSouth San Francisco, CA

(combination therapy), second-line non-Hodgkin’s lymphoma (com-

lymphoma (combination therapy)(see also leukemia)--------------------------------------------------second-line non-Hodgkin’s lymphoma (monotherapy)

-------------------------------------------

Onconova TherapeuticsNewtown, PA

(see also leukemia)

ONO PharmaceuticalOsaka, Japan

B-cell lymphomawww.ono.co.jp

oral azacitidine CelgeneSummit, NJ

(see also leukemia, lung, solid tumors) (908) 673-9000

(TORC1/TORC2 inhibitor) Farmingdale, NY

(see also kidney)(631) 962-0600

P 27600 Piramal Life SciencesMumbai, India

mantle cell lymphomawww.piramallifesciences.com

perifosine AEterna ZentarisBasking Ridge, NJ

lymphoma (combination therapy),

(see also brain, colorectal, kidney, leukemia, lung, multiple myeloma, sarcoma, solid tumors, stomach)

Progen PharmaceuticalsQueensland, Australia

(see also solid tumors)www.progen-pharma.com

pixantrone Cell TherapeuticsSeattle, WA

diffuse large B-cell lymphoma (see also breast)

PLX3397(CSF-1R kinase inhibitor)

PlexxikonBerkeley, CA

recurrent or refractory Hodgkin’s disease(see also brain, leukemia, solid tumors)

Medicines in Development for Cancer

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Medicines in Development Cancer 201260

LYMPHOMA

Product Name Sponsor Indication Development Status

Revlimid®

lenalidomideCelgeneSummit, NJ

non-Hodgkin’s lymphoma(see also leukemia) (908) 673-9000

RG7602 GenentechSouth San Francisco, CA

(see also solid tumors)

rigosertib Onconova TherapeuticsNewtown, PA

(see also leukemia, ovarian, pancreatic)

Rituxan®

rituxumab(fast infusion)

Weston, MA

GenentechSouth San Francisco, CA

non-Hodgkin’s lymphoma application submitted

Bridgewater, NJ

Exelixis South San Francisco, CA

non-Hodgkin’s lymphoma(see also breast)

(vorsetuzumab mafodotin)Seattle GeneticsBothell, WA

non-Hodgkin’s lymphoma(see also kidney)

Shape PharmaceuticalsCambridge, MA

cutaneous T-cell lymphomawww.shapepharma.com

sotrastaurin (AEB071)

Novartis PharmaceuticalsEast Hanover, NJ

diffuse large B-cell lymphoma(888) 669-6682

stem cell therapy Benitec BiopharmaSydney, Australia

City of Hope National Medical CenterDuarte, CA

www.benitec.com

teglarinad CephalonFrazer, PA

(see also solid tumors)

Telcyta™canfosfamide

TelikPalo Alto, CA

diffuse large B-cell lymphoma, mantle cell lymphoma, non-Hodgkin’s lymphoma (see also lung, ovarian)

thiarabine Access Pharmaceuticals (see also leukemia)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 61

LYMPHOMA

Product Name Sponsor Indication Development Status

tigatuzumab Daiichi SankyoParsippany, NJ

(see also breast, colorectal, liver, ovarian, pancreatic)

TKM-PLK1(RNAi)

Tekmira PharmaceuticalsBurnaby, Canada

(see also solid tumors)

trametinib GlaxoSmithKline (see also leukemia, lung, multiple myeloma, pancreatic, skin)

Treanda®

bendamustineCephalonFrazer, PA (combination therapy)

(see also leukemia, multiple myeloma)--------------------------------------------------second-line mantle cell lymphoma (combination therapy)

application submitted

-------------------------------------------

TRU-016(humanized anti-CD37 therapeutic)

Emergent BioSolutionsRockville, MD

non-Hodgkin’s lymphoma(see also leukemia)

Drais PharmaceuticalsBridgewater, NJ

(see also solid tumors)

Velcade®

bortezomibMillennium PharmaceuticalsCambridge, MA (see also leukemia, cancer-related,

other)--------------------------------------------------non-Hodgkin’s B-cell lymphoma

--------------------------------------------------diffuse large B-cell lymphoma

-------------------------------------------

-------------------------------------------

veltuzumabMorris Plains, NJ

non-Hodgkin’s lymphoma(see also leukemia)

Vidaza®

azacitidineCelgeneSummit, NJ

(see also leukemia)(908) 673-9000

VTX-2337 VentiRx PharmaceuticalsSeattle, WA

B-cell lymphoma(see also solid tumors)--------------------------------------------------lymphoma

-------------------------------------------

Medicines in Development for Cancer

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Medicines in Development Cancer 201262

LYMPHOMA

Product Name Sponsor Indication Development Status

XmAb®2513

(CD30-antigen inhibitor)XencorMonrovia, CA

Hodgkin’s disease, T-cell lymphoma

(sepantronium)Astellas Pharma US non-Hodgkin’s lymphoma

(see also breast)

zanolimumab(Orphan Drug)

Emergent BioSolutionsRockville, MD

cutaneous T-cell lymphoma

--------------------------------------------------peripheral T-cell lymphoma

-------------------------------------------

Zevalin®

ibritumomab tiuxetanSpectrum PharmaceuticalsHenderson, NV

second-line diffuse large B-cell lymphoma--------------------------------------------------mantle cell lymphoma

-------------------------------------------

Zolinza®

vorinostatMerckWhitehouse Station, NJ

B-cell lymphoma(see also breast, leukemia, lung, multiple myeloma, other)

(800) 672-6273

MULTIPLE MYELOMA

Product Name Sponsor Indication Development Status

(dalantercept)Acceleron PharmaCambridge, MA

(see also head/neck)

Actimid®

pomalidomide(Orphan Drug)

CelgeneSummit, NJ

recurrent multiple myeloma(see also lung, lymphoma, pancreatic)

application submitted(908) 673-9000

(HDAC6 inhibitor)Acetylon PharmaceuticalsBoston, MA

ALXN6000(samalizumab)

Alexion Pharmaceuticals (see also leukemia)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 63

MULTIPLE MYELOMA

Product Name Sponsor Indication Development Status

Aplidin®

plitidepsin(Orphan Drug)

PharmaMarMadrid, Spain

(see also lymphoma, solid tumors)www.pharmamar.com

Arno TherapeuticsFlemington, NJ

(see also leukemia, lymphoma)(862) 703-7170

(KSP inhibitor)Array BioPharmaBoulder, CO

multiple myeloma(see also leukemia, solid tumors)--------------------------------------------------multiple myeloma (combination therapy)

-------------------------------------------

(CDK inhibitor)Astex PharmaceuticalsDublin, CA

second-line multiple myeloma (see also leukemia, lymphoma, solid tumors)

AT9283(aurora/Jak2 inhibitor)

Astex PharmaceuticalsDublin, CA

(see also leukemia, lymphoma, solid tumors)

AUY922(Hsp90 inhibitor)

Novartis PharmaceuticalsEast Hanover, NJ

(see also breast, colorectal, lung, stomach) (888) 669-6682

BHQ880(mAb)

Novartis PharmaceuticalsEast Hanover, NJ

(see also solid tumors)(888) 669-6682

(Orphan Drug) Lund, Sweden

second-line late-stage multiple myeloma www.bioinvent.com

Kyowa Hakko Kirin PharmaPrinceton, NJ (609) 919-1100

(Orphan Drug)

Onyx PharmaceuticalsSouth San Francisco, CA

third-line multiple myeloma (Fast Track)(see also solid tumors)--------------------------------------------------multiple myeloma (combination therapy)

application submitted

-------------------------------------------

(noscapine)Cougar BiotechnologyRaritan, NJ www.cougarbiotechnology.com

(kinase inhibitor)CelgeneSummit, NJ

(see also lymphoma, solid tumors)(908) 673-9000

CC-122 CelgeneSummit, NJ

(see also lymphoma, solid tumors)(908) 673-9000

CC-223(mTOR inhibitor)

CelgeneSummit, NJ

(see also lung, lymphoma)(908) 673-9000

Medicines in Development for Cancer

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Medicines in Development Cancer 201264

MULTIPLE MYELOMA

Product Name Sponsor Indication Development Status

CP-18770(delanzomib)

CephalonFrazer, PA

(CK2 inhibitor)Cylene PharmaceuticalsSan Diego, CA

(see also solid tumors)

daratumumab GenmabPrinceton, NJ

darinaparsinNew York, NY

(see also liver, lymphoma, solid tumors)

GenentechSouth San Francisco, CA

refractory metastatic multiple myeloma

elotuzumab (BMS-901608)

Bristol-Myers SquibbPrinceton, NJ

ENMD-2076(Orphan Drug)

EntreMedRockville, MD

relapsed or refractory multiple myeloma(see also ovarian, other)

ganetespib (Hsp90i)

Synta PharmaceuticalsLexington, MA

second-line multiple myeloma(see also breast, colorectal, leukemia, liver, lung, pancreatic, prostate, skin, stomach)

GL-0817 GliknikBaltimore, MD

(see also head/neck)www.gliknik.com

GSK2110183(protein kinase B inhibitor)

GlaxoSmithKline (see also leukemia)

GVAX® Myeloma

cancer vaccineBioSante PharmaceuticalsLincolnshire, IL

ibrutinib Janssen BiotechHorsham, PA

PharmacyclicsSunnyvale, CA

(see also leukemia, lymphoma)

imetelstat GeronMenlo Park, CA

second-line multiple myeloma (monotherapy)(see also breast, leukemia, lung)

indatuximab ravtansine(Orphan Drug)

BiotestDreieich, Germany

relapsed or refractory multiple myeloma www.biotest.de

Medicines in Development for Cancer

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MULTIPLE MYELOMA

Product Name Sponsor Indication Development Status

(mTOR inhibitor) La Jolla, CA

(see also lymphoma, solid tumors)

Marseille, France

multiple myeloma (monotherapy)

--------------------------------------------------multiple myeloma (combination therapy)

www.innate-pharma.com-------------------------------------------

www.innate-pharma.com

Kyowa Hakko Kirin PharmaPrinceton, NJ

multiple myeloma (combination therapy) (609) 919-1100

(panobinostat)Novartis PharmaceuticalsEast Hanover, NJ

(see also kidney, leukemia, prostate, solid tumors) (888) 669-6682

lorvotuzumab mertansineWaltham, MA

(see also lung)

mapatumumab Human Genome SciencesRockville, MD

multiple myeloma (combination therapy)(see also liver, lung)

melphalan intravenous(captisol-enabled)(Orphan Drug)

CyDex PharmaceuticalsLenexa, KS www.ligand.com/cydex

milatuzumabMorris Plains, NJ

recurrent multiple myeloma(see also leukemia, lymphoma)

MLN9708(ixazomib)

Millennium PharmaceuticalsCambridge, MA

newly diagnosed multiple myeloma (combination therapy), second-line multiple myeloma(see also lymphoma, solid tumors)

Nexavar®

sorafenibBayer HealthCare PharmaceuticalsWayne, NJ

(see also breast, colorectal, head/neck, kidney, leukemia, liver, lung, ovarian, other)

(marizomib)Nereus PharmaceuticalsSan Diego, CA

(see also lymphoma, solid tumors)

obatoclax CephalonFrazer, PA

(see also leukemia, lung, lymphoma)

Medicines in Development for Cancer

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Medicines in Development Cancer 201266

MULTIPLE MYELOMA

Product Name Sponsor Indication Development Status

perifosine(Orphan Drug)

AEterna ZentarisBasking Ridge, NJ

recurrent multiple myeloma (combination therapy)(Fast Track)(see also brain, colorectal, kidney, leukemia, lung, lymphoma, sarcoma, solid tumors, stomach)

(MFGR-1877S)GenentechSouth San Francisco, CA

refractory metastatic multiple myeloma(see also solid tumors)

(antibody drug conjugate)GenentechSouth San Francisco, CA

injectionEUSA PharmaLanghorne, PA

(see also breast, prostate, sarcoma, other)

SF1126 Semafore PharmaceuticalsIndianapolis, IN

(see also leukemia, solid tumors)

siltuximab Janssen BiotechHorsham, PA

(see also prostate, other)

SNS01-T(nano-encapsulated gene therapy)(Orphan Drug)

Senesco TechnologiesBridgewater, NJ

second-line multiple myeloma

TH-302 Threshold PharmaceuticalsSouth San Francisco, CA

(see also brain, leukemia, pancreatic, sarcoma)

(dovitinib)Novartis PharmaceuticalsEast Hanover, NJ

(see also breast, kidney, prostate, skin, other) (888) 669-6682

trametinib GlaxoSmithKline multiple myeloma (see also leukemia, lung, lymphoma, pancreatic, skin)

Treanda®

bendamustineCephalonFrazer, PA

second-line multiple myeloma (combination therapy)(see also leukemia, lymphoma)

Xgeva™denosumab

Amgen (see also cancer-related, other)

Zolinza®

vorinostat(Orphan Drug)

MerckWhitehouse Station, NJ

metastatic multiple myeloma(see also breast, leukemia, lung, lymphoma, other)

(800) 672-6273

Medicines in Development for Cancer

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OVARIAN CANCER

Product Name Sponsor Indication Development Status

Å6 Angstrom PharmaceuticalsSolana Beach, CA

(see also other)

abagovomab(anti-idiotype mAb vaccine)(Orphan Drug)

MenariniFlorence, Italy www.menarini.com

Abraxane®

albumin-bound paclitaxelCelgeneSummit, NJ

(see also bladder, breast, lung, pancreatic, skin) (908) 673-9000

ABT-888 (veliparib)(PARP inhibitor)

Abbott LaboratoriesAbbott Park, IL

(see also brain, breast, colorectal, lung, lymphoma, prostate, skin, other)

AE37 peptide vaccine Antigen ExpressWorcester, MA

(see also breast)

AEZS-108(Orphan Drug)

AEterna ZentarisBasking Ridge, NJ

(see also bladder, prostate, other)

Avastin®

bevacizumab(Orphan Drug)

GenentechSouth San Francisco, CA

relapsed, platinum-sensitive ovarian cancer(see also brain, breast, colorectal, lung, other)--------------------------------------------------

application submitted

-------------------------------------------

BC-819 (gene therapy)(Orphan Drug)

BioCancell TherapeuticsJerusalem, Israel

late-stage ovarian cancer(see also bladder, pancreatic) www.biocancell.com

belinostat Spectrum PharmaceuticalsHenderson, NV

late-stage ovarian cancer (combination therapy)(see also colorectal, leukemia, liver, lung, lymphoma, other)

cabozantinib ExelixisSouth San Francisco, CA

(see also breast, kidney, lung, prostate, other)

catumaxomab Fresenius Biotech North AmericaWaltham, MA

(see also other)www.fresenius-biotech.com

CVac™MUC-1 cancer vaccine

Prima BioMedSydney, Australia www.primabiomed.com.au

Medicines in Development for Cancer

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Medicines in Development Cancer 201268

OVARIAN CANCER

Product Name Sponsor Indication Development Status

DCVax®-Ovarian

dendritic cell-based vaccineNorthwest BiotherapeuticsBethesda, MD

GenentechSouth San Francisco, CA

second-line ovarian cancer (see also other)

DPX-0907Halifax, Canada

(see also breast, prostate)

DPX-survivac cancer vaccineHalifax, Canada

(irofulven)EisaiWoodcliff Lake, NJ

(see also prostate, other)

EC20(technetium Tc-99m etarfolatide)

EndocyteWest Lafayette, IN

ovarian cancer (diagnosis)(see also lung) www.endocyte.com

(vintafolide)EndocyteWest Lafayette, IN

MerckWhitehouse Station, NJ

platinum-resistant ovarian cancer(see also lung) www.endocyte.com

(800) 672-6372

EGEN-001(Orphan Drug)

EGENHuntsville, AL

(see also colorectal, other)

elesclomol Synta PharmaceuticalsLexington, MA

(see also leukemia, lung)

ENMD-2076(Orphan Drug)

EntreMedRockville, MD

platinum-resistant ovarian cancer(see also multiple myeloma, other)

etirinotecan pegol (NKTR-102)(Orphan Drug)

Nektar TherapeuticsSan Francisco, CA

platinum-resistant ovarian cancer(see also breast, colorectal, solid tumors)

FANG™ Vaccine

autologous tumor cell vaccineGradalis adjuvant ovarian cancer

(see also colorectal, skin)

folate binding protein (E39) vaccine

Galena BiopharmaLake Oswego, OR

(see also breast, other)

iboctadekin GlaxoSmithKline (see also lymphoma)

Medicines in Development for Cancer

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OVARIAN CANCER

Product Name Sponsor Indication Development Status

vaccine Doylestown, PA

(see also breast)

iniparibBridgewater, NJ

(see also breast, lung)

Karenitecin®

cositecanBioNumerik Pharmaceuticals advanced ovarian cancer

(see also lung, solid tumors)

KHK-2866 Kyowa Hakko Kirin PharmaPrinceton, NJ

ovarian cancer (combination therapy)(see also solid tumors) (609) 919-1100

MerckWhitehouse Station, NJ

second-line ovarian cancer (800) 672-6372

MORAb-003(farletuzumab)

EisaiWoodcliff Lake, NJ

platinum-sensitive ovarian cancer(see also lung)

Nexavar®

sorafenibBayer HealthCare PharmaceuticalsWayne, NJ (see also breast, colorectal,

head/neck, kidney, leukemia, liver, lung, multiple myeloma, other)

OncoGenex PharmaceuticalsBothell, WA

(see also breast, lung)

olaratumab(LY3012207)

Eli LillyIndianapolis, IN

Bridgewater, NJ

(see also brain)

ombrabulin (AVE8062) Bridgewater, NJ

second-line ovarian cancer(see also lung, sarcoma)

Opaxio™paclitaxel poliglumex

Cell TherapeuticsSeattle, WA

(see also brain, lung, stomach, other)

oregovomab(Orphan Drug)

Quest PharmaTechEdmonton, Canada

inhibitor)Farmingdale, NY

(see also lung, other)(631) 962-0600

OVax®

autologous cell vaccine(Orphan Drug)

AVAX TechnologiesPhiladelphia, PA

Medicines in Development for Cancer

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Medicines in Development Cancer 201270

OVARIAN CANCER

Product Name Sponsor Indication Development Status

phenoxodiol Marshall EdwardsSan Diego, CA

second-line late-stage ovarian cancer (Fast Track)(see also prostate, other)

picoplatin Ponaird PharmaceuticalsSeattle, WA

(see also colorectal, lung, prostate)(206) 281-7001

Quinamed® CephalonFrazer, PA

(see also breast, prostate)

Reolysin®

reovirusOncolytics BiotechCalgary, Canada

ovarian cancer (combination therapy)(see also brain, colorectal, head/neck, lung, pancreatic, sarcoma, skin, solid tumors)--------------------------------------------------ovarian cancer (monotherapy)

-------------------------------------------

GenentechSouth San Francisco, CA

(antibody drug conjugate)GenentechSouth San Francisco, CA

(see also lung)

RG7600(antibody drug conjugate)

GenentechSouth San Francisco, CA

platinum-resistant ovarian cancer(see also pancreatic)

rigosertib Onconova TherapeuticsNewtown, PA

(see also leukemia, lymphoma, pancreatic)

rucaparib Clovis OncologyBoulder, CO

(see also breast)

sagopilone Bayer HealthCare PharmaceuticalsWayne, NJ

(see also breast, prostate)

(anti-ErbB3 mAb)Merrimack PharmaceuticalsCambridge, MA

Bridgewater, NJ

(see also breast, lung)

SG2000 SpirogenLondon, United Kingdom www.spirogen.com

squalamine(Orphan Drug)

OHR PharmaceuticalNew York, NY

resistant ovarian cancer

Telcyta™canfosfamide

TelikPalo Alto, CA

(see also lung, lymphoma)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 71

OVARIAN CANCER

Product Name Sponsor Indication Development Status

tigatuzumab Daiichi SankyoParsippany, NJ

(see also breast, colorectal, liver, lymphoma, pancreatic)

topotecan liposomes injection Talon TherapeuticsSan Mateo, CA

(see also lung)

trabectedin(Orphan Drug)

Johnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ

second-line ovarian cancer(see also breast, prostate, sarcoma)

(ENG protein inhibitor)TRACON PharmaceuticalsSan Diego, CA

(see also breast, prostate, other)

trebananib (AMG386)

Amgen (see also breast, colorectal, kidney, liver, stomach, other)

Vargatef™intedanib Pharmaceuticals (combination therapy)

(see also lung)

vosaroxin Sunesis PharmaceuticalsSouth San Francisco, CA

(see also leukemia)

Votrient™pazopanib

GlaxoSmithKline (see also kidney, other)

Zybrestat™fosbretabulin(Orphan Drug)

OXiGENESouth San Francisco, CA

(see also lung)

PANCREATIC CANCER

Product Name Sponsor Indication Development Status

Abraxane®

albumin-bound paclitaxel(Orphan Drug)

CelgeneSummit, NJ

(see also bladder, breast, lung, ovarian, skin) (908) 673-9000

Actimid®

pomalidomideCelgeneSummit, NJ

(see also lung, lymphoma, multiple myeloma) (908) 673-9000

Medicines in Development for Cancer

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PANCREATIC CANCER

Product Name Sponsor Indication Development Status

anti-MUC1 mAb Quest PharmaTechEdmonton, Canada

anti-PSCA mAb AgensysSanta Monica, CA

Astellas Pharma US

metastatic pancreatic cancer(combination therapy)

apricoxib(TG01)

Tragara PharmaceuticalsSan Diego, CA

pancreatic (combination therapy)(see also lung)

Archexin®

RX-0201(Orphan Drug)

Rexahn PharmaceuticalsRockville, MD

metastatic pancreatic cancer (combination therapy)

AgensysSanta Monica, CA

Seattle GeneticsBothell, WA

metastatic pancreatic cancer(see also prostate)

bavituximab Peregrine Pharmaceuticals(see also liver, lung)

BAY 86-9766(MEK inhibitor)

Ardea BiosciencesSan Diego, CA

Bayer HealthCare PharmaceuticalsWayne, NJ

(combination therapy)(see also liver)

BC-819 (gene therapy)(Orphan Drug)

BioCancell TherapeuticsJerusalem, Israel (combination therapy)

(Fast Track)(see also bladder, ovarian)

www.biocancell.com

Chk1 inhibitor(LY2603618)

Eli LillyIndianapolis, IN

(see also lung)

CO-101(lipid drug conjugate of gemcitabine)(Orphan Drug)

Clovis OncologyBoulder, CO cancer, second-line metastatic

pancreatic cancer

CO-101companion diagnostic

Clovis OncologyBoulder, CO

Ventana Medical Systems

pancreatic cancer (diagnosis) in clinical trials

(Orphan Drug)

Cornerstone PharmaceuticalsCranbury, NJ

combination therapy(see also other)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 73

PANCREATIC CANCER

Product Name Sponsor Indication Development Status

CRS-207(cancer vaccine)

Aduro BioTechBerkeley, CA

metastatic pancreatic cancer(combination therapy)

dalotuzumab MerckWhitehouse Station, NJ

(see also breast, lung, other)(800) 672-6372

encapsulated cell therapy(macrobeads) New York, NY

refractory metastatic pancreatic cancer(see also colorectal, prostate)

FG-3019(connective tissue growth factor)

FibroGenSan Francisco, CA

ganetespib (Hsp90i)

Synta PharmaceuticalsLexington, MA

(see also breast, colorectal, leukemia, liver, lung, multiple myeloma, prostate, skin, stomach)

ganitumab Amgen(combination therapy)(see also breast, colorectal, lung, sarcoma)

Louisville, CO

(see also colorectal, lung)

glufosfamide(Orphan Drug)

Eleison PharmaceuticalsPrinceton, NJ

pancreatic cancer (Fast Track)

(monoclonal antibody)Gilead SciencesFoster City, CA

(see also colorectal)

GV1001 (hTERT RNA vaccine)

KAEL-GemVaxSeoul, South Korea www.kaelgemvax.com

GVAX® Pancreatic

cancer vaccine(Orphan Drug)

BioSante PharmaceuticalsLincolnshire, IL

Aduro BioTechBerkeley, CA

HyperAcute® Pancreas

algenpantucel-L(Orphan Drug)

NewLink GeneticsAmes, IA

Châtenay-Malabry, France www.immutep.org

(Orphan Drug)

CytRxLos Angeles, CA

pancreatic ductal adenocarcinoma(see also sarcoma, solid tumors)

Medicines in Development for Cancer

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Medicines in Development Cancer 201274

PANCREATIC CANCER

Product Name Sponsor Indication Development Status

Istodax®

romidepsinCelgeneSummit, NJ

(see also kidney, prostate, other)(908) 673-9000

™ruxolitinib Wilmington, DE

(see also other)

KD032(ras/mTOR inhibitor)

Kadmon PharmaceuticalsWarrendale, PA

(see also lung)

(erismodegib)Novartis PharmaceuticalsEast Hanover, NJ

neoadjuvant pancreatic cancer(see also leukemia, solid tumors, skin)

(888) 669-6682

LE-DT(liposomal docetaxel) Phoenix, AZ (602) 910-2617

(low molecular weight heparin)Momenta PharmaceuticalsCambridge, MA

metastatic pancreatic cancer

masitinib AB Science USAShort Hills, NJ

(see also stomach)

MM-398(nanotherapeutic)(Orphan Drug)

Merrimack PharmaceuticalsCambridge, MA

metastatic pancreatic cancer

naptumomab estafenatox Active BiotechLund, Sweden

(see also kidney, lung)www.activebiotech.com

NPC-1C(ensituximab)(Orphan Drug)

Neogenix OncologyRockville, MD

late-stage, metastatic pancreatic cancer(see also colorectal)

(301) 917-6893

paclitaxel polymeric micelle formulation

Samyang BiopharmaceuticalsSeoul, South Korea

late-stage pancreatic cancerwww.samyangpharm.com

PancAtak™gene therapy

AdvantageneAuburndale, MA

PharmacyclicsSunnyvale, CA

metastatic pancreatic cancer (combination therapy)

PEGPH20(pegylated recombinant human hyaluronidase)

Halozyme TherapeuticsSan Diego, CA

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 75

PANCREATIC CANCER

Product Name Sponsor Indication Development Status

PHY906 PhytoCeutica (see also colorectal, liver, cancer-related)

polyclonal antibody stimulator(Orphan Drug)

Cancer AdvancesDurham, NC

(see also colorectal, stomach)(919) 361-2162

Reolysin®

reovirusOncolytics BiotechCalgary, Canada

pancreatic cancer (combination therapy)(see also brain, colorectal, head/neck, lung, ovarian, sarcoma, skin, solid tumors)

Rexin-G®

(Orphan Drug)

Epeius BiotechnologiesSan Marino, CA

metastatic pancreatic cancer(Fast Track)(see also breast, sarcoma)

RG7600(antibody drug conjugate)

GenentechSouth San Francisco, CA

platinum-resistant pancreatic cancer(see also ovarian)

rigosertib Onconova TherapeuticsNewtown, PA

(see also leukemia, lymphoma, ovarian)

RP101 RESprotectDresden, Germany www.resprotect.de

SecreFlo™synthetic human secretin

RepligenWaltham, MA

pancreatic cancer (diagnosis) Phase 0

SPRYCEL®

dasatinibBristol-Myers SquibbPrinceton, NJ

(see also brain, breast, prostate, other)

in clinical trials

TH-302 Threshold PharmaceuticalsSouth San Francisco, CA

(see also brain, leukemia, multiple myeloma, sarcoma)

tigatuzumab Daiichi SankyoParsippany, NJ

(see also breast, colorectal, liver, lymphoma, ovarian)

tivantinib (ARQ 197)

ArQuleWoburn, MA

Daiichi SankyoParsippany, NJ

(see also colorectal, kidney, liver, lung, sarcoma, other)

trametinib GlaxoSmithKline(see also leukemia, lung, lymphoma, multiple myeloma, skin)

uridine triacetate Gaithersburg, MD

(see also stomach)

Medicines in Development for Cancer

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Medicines in Development Cancer 201276

PANCREATIC CANCER

Product Name Sponsor Indication Development Status

Virulizin® Lorus Therapeutics

Y-90 clivatuzumab(Orphan Drug) Morris Plains, NJ (Fast Track)

PROSTATE CANCER

Product Name Sponsor Indication Development Status

Cambridge, MA

prostate cancer (diagnosis)

(nab®-docetaxel)CelgeneSummit, NJ cancer (908) 673-9000

ABT-888 (veliparib)(PARP inhibitor)

Abbott LaboratoriesAbbott Park, IL

(see also brain, breast, colorectal, lung, lymphoma, ovarian, skin, other)

AEZS-108 AEterna ZentarisBasking Ridge, NJ

(see also bladder, ovarian, other)

AgonOxPortland, OR (800) 979-7202

AP1903 Bellicum Pharmaceuticals (see also cancer-related)

Apatone®

ascorbic acid/menadione San Diego, CA

APC-100 Adamis PharmaceuticalsSan Diego, CA www.adamispharmaceuticals.

com

ARC-100 Archer BiosciencesNew York, NY

hormone-refractory prostate cancer(see also brain, breast, skin)

Aragon PharmaceuticalsSan Diego, CA

hormone-refractory prostate cancer

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 77

PROSTATE CANCER

Product Name Sponsor Indication Development Status

AgensysSanta Monica, CA

Seattle GeneticsBothell, WA

castration-resistant prostate cancer(see also pancreatic)

AT-101(oral pan Bcl-2 inhibitor)

Ascenta TherapeuticsMalvern, PA

hormone-refractory prostate cancer (combination therapy)(see also brain, leukemia, lung, lymphoma, stomach)--------------------------------------------------hormone-sensitive prostate cancer

-------------------------------------------

(androgen receptor down-regulator)

AstraZenecaWilmington, DE (800) 236-9933

bafetinib CytRx Los Angeles, CA

second-line metastatic hormone-refractory prostate cancer(see also brain, leukemia)

BPX-101(dendritic cell vaccine)

Bellicum Pharmaceuticals

cabozantinib ExelixisSouth San Francisco, CA

castration-resistant prostate cancer (see also breast, kidney, lung, ovarian, other)

CBLC102(mepacrine)

Cleveland BioLabsBuffalo, NY

Moscow, Russia

hormone-refractory prostate cancer

CD1089 (seocalcitol)

Cougar BiotechnologyRaritan, NJ www.cougarbiotechnology.com

cilengitide EMD SeronoRockland, MA

(see also brain)(800) 283-8088

custirsen(OGX-011/TV-1011)

OncoGenex PharmaceuticalsBothell, WA

Teva Pharmaceuticals

-tion therapy), second-line hormone-refractory prostate cancer (combina-tion therapy) (Fast Track)(see also lung)

EUSA PharmaLanghorne, PA

DPX-0907Halifax, Canada

(see also breast, ovarian)

Medicines in Development for Cancer

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Medicines in Development Cancer 201278

PROSTATE CANCER

Product Name Sponsor Indication Development Status

DSTP-3086S GenentechSouth San Francisco, CA

metastatic hormone-refractory prostate cancer

(irofulven)EisaiWoodcliff Lake, NJ

hormone-refractory prostate cancer(see also ovarian, other)

(anti-integrin mAb)EMD SeronoRockland, MA

metastatic castration-resistant prostate cancer (800) 283-8088

emepepimut-S EMD SeronoRockland, MA

OncothyreonSeattle, WA

newly-diagnosed prostate cancer(see also lung) (800) 283-8088

encapsulated cell therapy(macrobeads) New York, NY

refractory metastatic prostate cancer(see also colorectal, pancreatic)

enzalutamide(MDV3100)

Astellas Pharma

MedivationSan Francisco, CA

hormone-refractory prostate cancer(Fast Track)

EPO-806(patupilone)

Novartis PharmaceuticalsEast Hanover, NJ

(see also brain)(888) 669-6682

(antisense oligonucleotide)Enzon PharmaceuticalsPiscataway, NJ

Firmagon®

degarelixFerring PharmaceuticalsParsippany, NJ

3-month formulation

--------------------------------------------------neoadjuvant therapy

(973) 796-1600-------------------------------------------

(973) 796-1600

ganetespib (Hsp90i)

Synta PharmaceuticalsLexington, MA

second-line hormone-refractory prostate cancer(see also breast, colorectal, leukemia, liver, lung, multiple myeloma, pancreatic, skin, stomach)

Gleevec®

imatinibNovartis PharmaceuticalsEast Hanover, NJ

hormone-refractory prostate cancer(see also lung, skin, other) (888) 669-6682

GRNVAC1(dendritic cell vaccine)

Argos TherapeuticsDurham, NC

GeronMenlo Park, CA

(see also leukemia)

Medicines in Development for Cancer

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PROSTATE CANCER

Product Name Sponsor Indication Development Status

(selective estrogen receptoralpha agonist)

GTxsecond-line advanced prostate cancer

GVAX® Prostate

cancer vaccineBioSante PharmaceuticalsLincolnshire, IL

Aduro BioTechBerkeley, CA

(Fast Track)

Halaven®

eribulinEisaiWoodcliff Lake, NJ

(see also lung, sarcoma)

Harbor TherapeuticsSan Diego, CA

hormone-refractory prostate cancer

intetumumab Janssen BiotechHorsham, PA

(see also skin)

Santa Ana, CA www.io-therapeutics.com

RxCarlsbad, CA

prostate cancer (combination therapy)(see also lung)

Istodax®

romidepsinCelgeneSummit, NJ

(see also kidney, pancreatic, other)(908) 673-9000

(anti-PMSA mAb)BZL BiologicsNew York, NY

metastatic prostate cancer, non-metastatic prostate cancer

(Hdm2 inhibitor)Johnson & Johnson Pharmaceutical Research & DevelopmentRaritan, NJ

(see also lung, solid tumors)

KX2-391 Kinex PharmaceuticalsBuffalo, NY

(see also leukemia)(716) 898-8626

(panobinostat)Novartis PharmaceuticalsEast Hanover, NJ

(see also kidney, leukemia, multiple myeloma, solid tumors) (888) 669-6682

LFA102(anti-prolactin receptor antibody)

Novartis PharmaceuticalsEast Hanover, NJ

XOMABerkeley, CA

(see also breast)(888) 669-6682

Lorus Therapeutics metastatic prostate cancer(see also breast, colorectal, kidney, leukemia)

Medicines in Development for Cancer

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Medicines in Development Cancer 201280

PROSTATE CANCER

Product Name Sponsor Indication Development Status

(GnRH antagonist)Merrion PharmaceuticalsWilmington, DE

MVA-BN® PRO

antigen cancer vaccine Mountain View, CA

NeuVax™ Galena BiopharmaLake Oswego, OR

(see also breast)

nimotuzumab YM Biosciences USALehigh Valley, PA

(see also brain, breast)

NX-1207 Nymox PharmaceuticalQuebec, Canada (800) 936-9669

ODM-201(androgen receptor antagonist)

Endo PharmaceuticalsChadds Ford, PA

OrionEspoo, Finland

castration-resistant prostate cancer

oncolytic virus CZ BioMed

anti-idiotype cancer vaccine VaxOncoSeoul, South Korea www.vaxonco.com

Onyvax-P(prostate cancer vaccine)

VaxOncoSeoul, South Korea

ozarelix Spectrum PharmaceuticalsHenderson, NV

hormone-dependent prostate cancer

PEG arginine deiminase Polaris PharmaceuticalsSan Diego, CA

prostate cancer (combination therapy)(see also liver, skin, other)

phenoxodiol Marshall EdwardsSan Diego, CA

prostate cancer (Fast Track)(see also ovarian, other)

picoplatin Ponaird PharmaceuticalsSeattle, WA

(see also colorectal, lung, prostate)(206) 281-7001

ProstAtak™gene therapy

AdvantageneAuburndale, MA

adjuvant prostate cancer(Fast Track)

Medicines in Development for Cancer

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PROSTATE CANCER

Product Name Sponsor Indication Development Status

prostate cancer vaccine(anti-GnRH)

Novartis Vaccines & DiagnosticsCambridge, MA

Pepscan TherapeuticsLelystad, Netherlands

(617) 871-7000

Prostvac™rilimogene galvacirepvec Mountain View, CA

castration-resistant prostate cancer(Fast Track)

Provenge®

sipuleucel-TDendreonSeattle, WA

recurrent early-stage prostate cancer

--------------------------------------------------neoadjuvant early-stage prostate cancer

-------------------------------------------

PRX-302 Sophiris BioLa Jolla, CA

PSMA ADC(anti-drug conjugate)

Progenics Pharmaceuticals

PSMA protein vaccine(recombinant soluble)

Progenics Pharmaceuticals

PSMA VRP therapeutic vaccine Progenics Pharmaceuticals

PX-866 OncothyreonSeattle, WA

hormone-refractory prostate cancer(see also brain, head/neck, lung) (206) 801-2100

Quinamed® CephalonFrazer, PA

(see also breast, ovarian)

Momotaro-GeneOkayama, Japan www.mt-gene.com

ridaforolimusCambridge, MA

MerckWhitehouse Station, NJ

(see also breast, kidney, lung, sarcoma, other) (800) 672-6372

sagopilone Bayer HealthCare PharmaceuticalsWayne, NJ

(see also breast, ovarian)

injectionEUSA PharmaLanghorne, PA

(see also breast, multiple myeloma, sarcoma, other)

siltuximab Janssen BiotechHorsham, PA

hormone-refractory prostate cancer(see also multiple myeloma, other)

Medicines in Development for Cancer

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Medicines in Development Cancer 201282

PROSTATE CANCER

Product Name Sponsor Indication Development Status

SPRYCEL®

dasatinibBristol-Myers SquibbPrinceton, NJ

(see also brain, breast, pancreatic, other)

in clinical trials

Millennium PharmaceuticalsCambridge, MA

TAK-700 (orteronel)

Millennium PharmaceuticalsCambridge, MA (combination therapy), second-line

metastatic prostate cancer(combination therapy)--------------------------------------------------prostate cancer

-------------------------------------------

tasquinimod(TASQ)

Active BiotechLund, Sweden

metastatic prostate cancer

--------------------------------------------------second-line metastatic prostate cancer

www.activebiotech.com-------------------------------------------

www.activebiotech.com

TeloB-Vax

telomerase cancer vaccineAdamis PharmaceuticalsSan Diego, CA www.adamispharmaceuticals.

com

tesetaxel GentaBerkeley Heights, NJ

(see also bladder, breast, skin, stomach) (908) 286-9800

tigapotide Kotinos PharmaceuticalsNew York, NY

hormone-refractory prostate cancer

(dovitinib)Novartis PharmaceuticalsEast Hanover, NJ

(see also breast, kidney, multiple myeloma, skin, other) (888) 669-6682

TNFerade™golnerminogene pradenovec

GenVecGaithersburg, MD

(see also head/neck, skin, stomach)

TOK-001 Tokai PharmaceuticalsCambridge, MA

castration-resistant prostate cancer

trabectedin Johnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ

(see also breast, ovarian, sarcoma)

(ENG protein inhibitor)TRACON PharmaceuticalsSan Diego, CA

(see also breast, ovarian, other)

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 83

PROSTATE CANCER

Product Name Sponsor Indication Development Status

Trofex™Cambridge, MA

prostate cancer (diagnosis)

TroVax®

tumor-associated antigen vaccine

Oxford BioMedicaOxford, United Kingdom

hormone-refractory prostate cancer(combination therapy) www.oxfordbiomedica.co.uk

Viamet PharmaceuticalsMorrisville, NC

YERVOY®

ipilimumabBristol-Myers SquibbPrinceton, NJ

prostate cancer (post-hormonal therapy), prostate cancer (post-chemotherapy)(see also lung, skin)

in clinical trials

Zaltrap™ Regeneron Pharmaceuticals

Bridgewater, NJ

prostate cancer(see also colorectal)

Zytiga®

abirateroneJanssen BiotechHorsham, PA (see also breast)

--------------------------------------------------neoadjuvant prostate cancer

-------------------------------------------

SARCOMA

Product Name Sponsor Indication Development Status

United TherapeuticsSilver Spring, MD

soft tissue sarcoma(see also brain, other) (301) 608-9292

abexinostat(HDAC inhibitor)

PharmacyclicsSunnyvale, CA

sarcoma(see also lymphoma)

brivanib(VEGFR/FGFR kinase inhibitor)

Bristol-Myers SquibbPrinceton, NJ

(see also colorectal, liver)

cancer vaccine MabVax TherapeuticsSan Diego, CA

(see also breast)

ganitumab Amgen (see also breast, colorectal, lung, pancreatic)

Halaven®

eribulinEisaiWoodcliff Lake, NJ

(see also lung, prostate)

Medicines in Development for Cancer

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Medicines in Development Cancer 201284

SARCOMA

Product Name Sponsor Indication Development Status

(Orphan Drug)

CytRxLos Angeles, CA

soft tissue sarcoma(see also pancreatic, solid tumors)

Junovan™mifamurtide(Orphan Drug)

Millennium PharmaceuticalsCambridge, MA

osteosarcoma

ombrabulin (AVE8062) Bridgewater, NJ

(see also lung, ovarian)

palifosfamide

(Orphan Drug)

New York, NY (combination therapy)(see also lung, solid tumors)--------------------------------------------------second-line soft tissue sarcoma (combination therapy)--------------------------------------------------soft tissue sarcoma (monotherapy)

-------------------------------------------

-------------------------------------------

perifosine AEterna ZentarisBasking Ridge, NJ

(see also brain, colorectal, kidney, leukemia, lung, lymphoma, multiple myeloma, solid tumors, stomach)

PharmaMarMadrid, Spain

Ewing’s sarcoma(see also cervical, other) www.pharmamar.com

Reolysin®

reovirusOncolytics BiotechCalgary, Canada

(see also brain, colorectal, head/neck, lung, ovarian, pancreatic, skin, solid tumors)

Rexin-G®

(Orphan Drug)

Epeius BiotechnologiesSan Marino, CA

osteosarcoma(see also breast, pancreatic)--------------------------------------------------soft tissue sarcoma

-------------------------------------------

ridaforolimus(Orphan Drug) Cambridge, MA

MerckWhitehouse Station, NJ

metastatic sarcoma (Fast Track)(see also breast, kidney, lung, prostate, other)--------------------------------------------------sarcoma

application submitted(800) 672-6372

-------------------------------------------

(800) 672-6372

robatumumab MerckWhitehouse Station, NJ

osteosarcoma, sarcoma(see also colorectal, solid tumors) (800) 672-6372

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 85

SARCOMA

Product Name Sponsor Indication Development Status

injectionEUSA PharmaLanghorne, PA

osteosarcoma(see also breast, multiple myeloma, prostate, other)

saridegib(Orphan Drug) Cambridge, MA

chondrosarcoma (inoperable/unresectable)

TH-302(Orphan Drug)

Threshold PharmaceuticalsSouth San Francisco, CA

soft tissue sarcoma(see also brain, leukemia, multiple myeloma, pancreatic)

tivantinib (ARQ 197)(Orphan Drug)

ArQuleWoburn, MA

Daiichi SankyoParsippany, NJ

soft tissue sarcoma(see also colorectal, kidney, liver, lung, pancreatic, other)

trabectedin(Orphan Drug)

Johnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ

soft tissue sarcoma(see also breast, ovarian, prostate)--------------------------------------------------soft tissue sarcoma (adolescents and children)

-------------------------------------------

SKIN CANCER

Product Name Sponsor Indication Development Status

Abraxane®

albumin-bound paclitaxel(Orphan Drug)

CelgeneSummit, NJ

malignant melanoma(see also bladder, breast, lung, ovarian, pancreatic)

(908) 673-9000

ABT-888 (veliparib)(PARP inhibitor)

Abbott LaboratoriesAbbott Park, IL

malignant melanoma(see also brain, breast, colorectal, lung, lymphoma, ovarian, prostate, other)

New York, NY

malignant melanoma

Allovectin®

velimogene aliplasmid(Orphan Drug)

VicalSan Diego, CA

Medicines in Development for Cancer

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Medicines in Development Cancer 201286

SKIN CANCER

Product Name Sponsor Indication Development Status

ALT-801 Altor BioScienceMiramar, FL

malignant melanoma(see also other)

anti-PD1 Bristol-Myers SquibbPrinceton, NJ

melanoma(see also kidney, lung)

APN301

fusion protein)

Apeiron BiologicsVienna, Austria

malignant melanoma(see also brain) www.apeiron-biologics.com

ARC-100 Archer BiosciencesNew York, NY

malignant melanoma (combination therapy)(see also brain, breast, prostate)

ARRY-162(MEK inhibitor)

Array BioPharmaBoulder, CO

malignant melanoma (BRAFV600E or NRAS mutations) (see also solid tumors)

astuprotimut-R

cancer immunotherapeutic)

GlaxoSmithKline malignant melanoma(see also lung)--------------------------------------------------inoperable/unresectable malignant melanoma

-------------------------------------------

autologous stem cell therapy California Stem CellsIrvine, CA

malignant melanoma

CytotechNatick, MA

basal cell cancer, squamous call cancer

Cavatak™coxsackievirus A21(Orphan Drug)

ViralyticsPymble, Australia

malignant melanomawww.viralytics.com

CB-10-01cancer vaccine

Cosmo PharmaceuticalsLainate, Italy

malignant melanomawww.cosmopharmaceuticals.com

CDX-011(glembatumumab vedotin)

Celldex TherapeuticsNeedham, MA

malignant melanoma(see also breast)

CYT107(interleukin-7)

CytherisRockville, MD

malignant melanoma(see also kidney)

New York, NY

malignant melanoma

GenentechSouth San Francisco, CA

malignant melanoma

Medicines in Development for Cancer

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SKIN CANCER

Product Name Sponsor Indication Development Status

dendritic cancer cell vaccine EMD MilliporeBillerica, MA

malignant melanoma

EisaiWoodcliff Lake, NJ

late-stage malignant melanoma(see also brain, head/neck, liver, solid tumors, stomach)

E7080(lenvatinib)

EisaiWoodcliff Lake, NJ

melanoma(see also brain, other)

ecromeximab Life Science Pharmaceuticals malignant melanoma (combination therapy)

Erivedge™vismodegib

GenentechSouth San Francisco, CA

early-stage basal cell cancer (resectable)

FANG™ Vaccine

autologous tumor cell vaccineGradalis malignant melanoma

(see also colorectal, ovarian)

ganetespib (Hsp90i)

Synta PharmaceuticalsLexington, MA

malignant melanoma(see also breast, colorectal, leukemia, liver, lung, multiple myeloma, pancreatic, prostate, stomach)

GDC-0973(MEK inhibitor)

GenentechSouth San Francisco, CA

second-line metastatic malignant melanoma (combination therapy) (see also solid tumors)

Gleevec®

imatinibNovartis PharmaceuticalsEast Hanover, NJ

malignant melanoma(see also lung, prostate, other) (888) 669-6682

(BRaf protein kinase inhibitor)GlaxoSmithKline

stage malignant melanoma(see also brain, lung)

--------------------------------------------------BRAF mutation-positive metastatic malignant melanoma (combination therapy)

-------------------------------------------

(cancer vaccine)GlaxoSmithKline metastatic malignant melanoma

(cancer vaccine)GlaxoSmithKline

melanoma

Medicines in Development for Cancer

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Medicines in Development Cancer 201288

SKIN CANCER

Product Name Sponsor Indication Development Status

HyperAcute® Melanoma

melanoma vaccineNewLink GeneticsAmes, IA

malignant melanoma

(cancer vaccine) Oxon, United Kingdom

malignant melanoma Phase 0www.immunocore.com

Imprime PGG® BiotheraEagan, MN

malignant melanoma(see also colorectal, leukemia, lung)

Wilmington, DE

malignant melanoma(see also solid tumors)

interleukin-12 gene therapy OncoSec MedicalSan Diego, CA

malignant melanoma, merkel cell carcinoma(see also lymphoma)

www.oncosec.com

intetumumab Janssen BiotechHorsham, PA

malignant melanoma(see also prostate)

(erismodegib)Novartis PharmaceuticalsEast Hanover, NJ

basal cell cancer(see also leukemia, pancreatic, solid tumors)

(888) 669-6682

inhibitor)

Novartis PharmaceuticalsEast Hanover, NJ

malignant melanoma(see also breast) (888) 669-6682

LGX818(RAF inhibitor)

Novartis PharmaceuticalsEast Hanover, NJ

metastatic malignant melanoma(see also colorectal) (888) 669-6682

Lymphoseek®

Tc-99m tilmanoceptNavidea PharmaceuticalsDublin, OH

malignant melanoma (diagnosis)(see also breast, head/neck)

application submitted

M-200 prophage cancer vaccine(vitespen)(Orphan Drug)

AgenusLexington, MA

metastatic melanoma(Fast Track)

Marqibo®

vincristine liposomal(Orphan Drug)

Talon TherapeuticsSan Mateo, CA

malignant melanoma(see also leukemia, lymphoma, other)

melanoma DNA vaccineSan Diego, CA

Memorial Sloan-Kettering Cancer CenterNew York, NY

malignant melanoma

EisaiWoodcliff Lake, NJ

malignant melanoma

Medicines in Development for Cancer

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SKIN CANCER

Product Name Sponsor Indication Development Status

(Orphan Drug)

Progen PharmaceuticalsQueensland, Australia

malignant melanoma(see also liver) www.progen.com.au

MVax®

melanoma vaccineAVAX TechnologiesPhiladelphia, PA

malignant melanoma

NX-101 NexGenixNew York, NY

Ontak®

denileukin diftitoxEisaiWoodcliff Lake, NJ

malignant melanoma

PEG arginine deiminase Polaris PharmaceuticalsSan Diego, CA

metastatic malignant melanoma (see also liver, prostate, other)

Picato®

ingenol mebutateLEO PharmaParsippany, NJ

basal cell cancer

POL-103A(melanoma vaccine)(Orphan Drug)

PolynomaSan Diego, CA

malignant melanoma

immunotherapeutic (recombinant)

GlaxoSmithKline metastatic malignant melanoma(see also lung)

Pain Therapeutics malignant melanoma

PV-10(rose bengal sodium)(Orphan Drug)

Provectus Pharmaceuticals malignant melanoma(see also liver)

(raf kinase inhibitor)Novartis PharmaceuticalsEast Hanover, NJ

malignant melanoma(see also solid tumors) (888) 669-6682

Reolysin®

reovirusOncolytics BiotechCalgary, Canada

malignant melanoma(see also brain, colorectal, head/neck, lung, ovarian, pancreatic, sarcoma, solid tumors)

(BRAF kinase inhibitor)RocheNutley, NJ

malignant melanoma

RG7636(antibody drug conjugate)

RocheNutley, NJ

malignant melanoma

Medicines in Development for Cancer

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SKIN CANCER

Product Name Sponsor Indication Development Status

talminogene laherparepvec Amgen malignant melanoma

Tasigna®

nilotinibNovartis PharmaceuticalsEast Hanover, NJ

malignant melanoma (c-Kit mutation)(see also leukemia, stomach) (888) 669-6682

tesetaxel(Orphan Drug)

GentaBerkeley Heights, NJ

malignant melanoma(see also bladder, breast, prostate, stomach)

(908) 286-9800

(dovitinib)Novartis PharmaceuticalsEast Hanover, NJ

malignant melanoma(see also breast, kidney, multiple myeloma, prostate, other)

(888) 669-6682

TNFerade™golnerminogene pradenovec

GenVecGaithersburg, MD

malignant melanoma(see also head/neck, prostate, stomach)

trametinib GlaxoSmithKline malignant melanoma (monotherapy)(see also leukemia, lung, lymphoma, multiple myeloma, pancreatic)--------------------------------------------------malignant melanoma (combination therapy)

-------------------------------------------

veglin (VEGF antisense)

VasGene TherapeuticsLos Angeles, CA

Kaposi’s sarcoma(see also lung, kidney) (323) 221-7818

YERVOY®

ipilimumabBristol-Myers SquibbPrinceton, NJ

melanoma (adjuvant therapy),melanoma brain metastases(see also lung, prostate)

in clinical trials

Zadaxin®

thymalfasin alfa 1(Orphan Drug)

SciClone PharmaceuticalsFoster City, CA

malignant melanoma(see also liver)

SOLID TUMORS

Product Name Sponsor Indication Development Status

AbGn-7 AbGenomicsLos Altos, CA

(sirolimus albumin bound)CelgeneSummit, NJ (908) 673-9000

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

(aurora kinase inhibitor)Abbott LaboratoriesAbbott Park, IL

late-stage solid tumors(see also other)

ABT-700(c-Met inhibitor)

Abbott LaboratoriesAbbott Park, IL

ABT-767(PARP inhibitor)

Abbott LaboratoriesAbbott Park, IL

ABT-806(EGFR inhibitor)

Abbott LaboratoriesAbbott Park, IL

AC220(quizartinib)

Ambit BiosciencesSan Diego, CA

Astellas Pharma US

(see also leukemia)

AEZS-112 AEterna Zentaris Basking Ridge, NJ

(see also lymphoma)

AcusphereLexington, MA

(tubulin inhibitor) Albany, NY

Bessor PharmaFramingham, MA

www.amriglobal.com

AlloStim™Shoham, Israel

(see also other)www.immunovative.co.il

Alocrest™vinorelbine liposomal

Talon TherapeuticsSan Mateo, CA

(see also lymphoma)

AMG 208(c-Met inhibitor)

Amgen

AMG 337(c-Met inhibitor)

Amgen

AMG 780(angioprotein inhibitor)

Amgen

AMG 820(c-fms antagonist)

Amgen

Medicines in Development for Cancer

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Medicines in Development Cancer 201292

SOLID TUMORS

Product Name Sponsor Indication Development Status

AMG 900(aurora kinase inhibitor)

Amgen (see also other)

AmplimmuneGaithersburg, MD (301) 309-9800

anti-CD137 Bristol-Myers SquibbPrinceton, NJ

GenentechSouth San Francisco, CA

anti-PD-L1 Bristol-Myers SquibbPrinceton, NJ

Aplidin®

plitidepsinPharmaMarMadrid, Spain

(see also lymphoma, multiple myeloma) www.pharmamar.com

AR-12 Arno TherapeuticsFlemington, NJ

(see also lymphoma)(862) 703-7170

AR-67 Arno TherapeuticsFlemington, NJ

(see also brain, leukemia)(862) 703-7170

ARQ 092(AKT inhibitor)

ArQuleWoburn, MA

Daiichi SankyoParsippany, NJ

inoperable/unresectable late-stage solid tumors

ARQ 621 ArQuleWoburn, MA

late-stage solid tumors(see also other)

ARQ 736(BRAF inhibitor)

ArQuleWoburn, MA

late-stage solid tumors

ARQ 761(E2F1 stimulant)

ArQuleWoburn, MA

ARRY-162(MEK inhibitor)

Array BioPharmaBoulder, CO

late-stage solid tumors(see also skin)

(KSP inhibitor)Array BioPharmaBoulder, CO

(see also leukemia, multiple myeloma)

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

ASG-22ME AgensysSanta Monica, CA

Seattle GeneticsBothell, WA

ASP3026 Astellas Pharma US late-stage solid tumors(see also lymphoma)

(CDK inhibitor)Astex PharmaceuticalsDublin, CA

(see also leukemia, lymphoma, multiple myeloma)

AT9283(aurora/Jak2 inhibitor)

Astex PharmaceuticalsDublin, CA

(see also leukemia, lymphoma, multiple myeloma)

AT13387(Hsp90 inhibitor)

Astex PharmaceuticalsDublin, CA

refractory solid tumors(see also stomach)

(docetaxel liposomal)Azaya Therapeutics

(JAK1/JAK2 inhibitor)AstraZenecaWilmington, DE (800) 236-9933

(TOR kinase inhibitor)AstraZenecaWilmington, DE (800) 236-9933

(FGFR tyrosine kinase inhibitor)AstraZenecaWilmington, DE (800) 236-9933

(AKT inhibitor)Astex PharmaceuticalsDublin, CA

AstraZenecaWilmington, DE

(800) 236-9933

AZD8330

(MEK inhibitor)

Array BioPharmaBoulder, CO

AstraZenecaWilmington, DE

(800) 236-9933

AZD8931(erbB kinase inhibitor)

AstraZenecaWilmington, DE

(see also breast)(800) 236-9933

(Pan-CDK inhibitor)Bayer HealthCare PharmaceuticalsWayne, NJ

late-stage solid tumors

(antibody-drug conjugate)Bayer HealthCare PharmaceuticalsWayne, NJ

Medicines in Development for Cancer

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Medicines in Development Cancer 201294

SOLID TUMORS

Product Name Sponsor Indication Development Status

Bayer HealthCare PharmaceuticalsWayne, NJ

ἀ pathway inhibitor)Bayer HealthCare PharmaceuticalsWayne, NJ

(antibody drug conjugate)Bayer HealthCare PharmaceuticalsWayne, NJ

(stemness kinase inhibitor)Boston BiomedicalNorwood, MA

late-stage solid tumors(781) 278-0900

(stemness inhibitor)Boston BiomedicalNorwood, MA

late-stage solid tumors(781) 278-0900

belotecan OnKor PharmaceuticalsSeattle, WA

(kinase inhibitor)Novartis PharmaceuticalsEast Hanover, NJ (888) 669-6682

BGJ398(FGF-R kinase inhibitor)

Novartis PharmaceuticalsEast Hanover, NJ (888) 669-6682

BGT226 Novartis PharmaceuticalsEast Hanover, NJ (888) 669-6682

BHQ880(mAb)

Novartis PharmaceuticalsEast Hanover, NJ

(see also multiple myeloma)(888) 669-6682

(aurora kinase B inhibitor) Pharmaceuticals(see also leukemia)

Pharmaceuticals

Pharmaceuticals

Pharmaceuticals

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

(TYK2 inhibitor) Pharmaceuticals

Cambridge, MA (617) 679-2000

Cambridge, MA (617) 679-2000

(docetaxel nanopharmaceutical) Cambridge, MA

BMN-673(PARP inhibitor)

BioMarin PharmaceuticalsNovato, CA

(see also other)

Novartis PharmaceuticalsEast Hanover, NJ (888) 669-6682

BYL719 Novartis PharmaceuticalsEast Hanover, NJ

late-stage solid tumors(888) 669-6682

CA-18C3 XBiotech (see also cancer-related, other)

CALAA 01(siRNA)

Calando PharmaceuticalsPasadena, CA (626) 683-7200

Onyx PharmaceuticalsSouth San Francisco, CA

(see also multiple myeloma)

(peptide mimetic)CanBasShizouka, Japan

(see also lung)www.canbas.co.jp

(kinase inhibitor)CelgeneSummit, NJ

(see also lymphoma, multiple myeloma) (908) 673-9000

CC-122 CelgeneSummit, NJ

(see also lymphoma, multiple myeloma) (908) 673-9000

CDX-1127 Celldex TherapeuticsNeedham, MA

(see also other)

(cancer vaccine)Celldex TherapeuticsNeedham, MA

solid tumors expressing theNY-ESO-1 protein

CEP-11981 CephalonFrazer, PA

Medicines in Development for Cancer

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Medicines in Development Cancer 201296

SOLID TUMORS

Product Name Sponsor Indication Development Status

CG201(cancer vaccine)

CG TherapeuticsSeattle, WA

CRLX101 Cerulean PharmaCambridge, MA

late-stage solid tumors

crolibulin EpiCept

CUDC-101 CurisLexington, MA

CVX 060

(Ang2 antagonist)New York, NY

(see also kidney)

(CK2 inhibitor)Cylene PharmaceuticalsSan Diego, CA

(see also multiple myeloma)

CYC116(aurora kinase/VEGFR2 inhibitor)

Cyclacel PharmaceuticalsBerkeley Heights, NJ

CYT-6091(Aurimune) Rockville, MD

D-1MT NewLink GeneticsAmes, IA

(see also breast)

D-3263(TRPM8 protein stimulant)

DendreonSeattle, WA

dacomitinibNew York, NY

(see also lung)

darinaparsinNew York, NY

(see also liver, lymphoma, multiple myeloma)

Daiichi SankyoParsippany, NJ

Daiichi SankyoParsippany, NJ

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

EisaiWoodcliff Lake, NJ

metastatic solid tumors(see also brain, head/neck, liver, skin, stomach)

EC17 EndocyteWest Lafayette, IN www.endocyte.com

EndocyteWest Lafayette, IN www.endocyte.com

elsamitrucin Spectrum PharmaceuticalsHenderson, NV

late-stage solid tumors

(c-Met kinase inhibitor)EMD SeronoRockland, MA (800) 283-8088

enavatuzumab Abbott LaboratoriesAbbott Park, IL

EP-100 Esperance PharmaceuticalsBaton Rouge, LA

ETBX-011cancer vaccine

EtubicsSeattle, WA

late-stage metastatic solid tumors

etirinotecan pegol (NKTR-102)

Nektar TherapeuticsSan Francisco, CA

combination therapy(see also breast, colorectal, ovarian)

EZN-2208 Enzon PharmaceuticalsPiscataway, NJ

solid tumors (pediatric)(see also breast, colorectal)--------------------------------------------------combination therapy

-------------------------------------------

EZN-2968 Enzon PharmaceuticalsPiscataway, NJ

(see also lymphoma)

(AV-299)AVEO PharmaceuticalsCambridge, MA

(see also lung)

GE HealthcareWaukesha, WI

Bethesda, MD

solid tumors (diagnosis)

FP-1039/HGS1036 Five Prime TherapeuticsSouth San Francisco, CA

Human Genome SciencesRockville, MD

late-stage solid tumors

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

G-202 GenSpera

GC1008(fresolimumab)

GenzymeCambridge, MA

GDC-0032 GenentechSouth San Francisco, CA

metastatic solid tumors

GDC-0068(Akt inhibitor)

GenentechSouth San Francisco, CA

(small molecule)GenentechSouth San Francisco, CA

(see also lymphoma)

(ChK1 inhibitor)GenentechSouth San Francisco, CA

(see also lymphoma)

GenentechSouth San Francisco, CA

(see also lymphoma)

GDC-0623(MEK inhibitor)

GenentechSouth San Francisco, CA

metastatic solid tumors

GDC-0917 GenentechSouth San Francisco, CA

(see also lymphoma)

GDC-0973(MEK inhibitor)

GenentechSouth San Francisco, CA

(see also skin cancer)

GDC-0980

inhibitor)

GenentechSouth San Francisco, CA

(see also breast, lymphoma)

(toposisomerase-1 inhibitor)GenzymeCambridge, MA

KiraxBonita Springs, FL

(brachyury peptide vaccine) Louisville, CO

GL-ONC1 GeneluxSan Diego, CA

GO-203-2c Genus OncologyVernon Hills, IL

late-stage solid tumors

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

(polio-like kinase inhibitor)GlaxoSmithKline (see also lymphoma)

GSK690693(AKT kinase inhibitor)

GlaxoSmithKline (see also lymphoma)

GSK1070916A(selective aurora kinase B/C inhibitor)

GlaxoSmithKline

GlaxoSmithKline (see also lymphoma)

(protein kinase B inhibitor)GlaxoSmithKline (see also lymphoma)

(FAK inhibitor)GlaxoSmithKline

GSK2636771 GlaxoSmithKline

HSP990(heat shock protein)

Novartis PharmaceuticalsEast Hanover, NJ (888) 669-6682

Bristol-Myers SquibbPrinceton, NJ

(cancer vaccine)NY-ESO-1 antigen-expressing solid tumors www.immunofrontier.com

Waltham, MA

(c-Met inhibitor)Novartis PharmaceuticalsEast Hanover, NJ (888) 669-6682

Wilmington, DE

(see also skin)

indium-111 (ABT-806) Abbott LaboratoriesAbbott Park, IL

solid tumors (diagnosis)

(mTOR inhibitor) La Jolla, CA

(see also lymphoma, multiple myeloma)

La Jolla, CA

Medicines in Development for Cancer

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Medicines in Development Cancer 2012100

SOLID TUMORS

Product Name Sponsor Indication Development Status

CytRxLos Angeles, CA

(see also pancreatic, sarcoma)

CytRxLos Angeles, CA

(see also leukemia)

(angiogenesis inhibitor)Jubilant BiosysMalvern, PA

(Hdm2 inhibitor)Johnson & Johnson Pharmaceutical Research & DevelopmentRaritan, NJ

late-stage solid tumors(see also lung, prostate)

JX-929 Jennerex BiotherapeuticsSan Francisco, CA

Karenitecin® BioNumerik Pharmaceuticals solid tumors (adults and pediatric)(see also lung, ovarian)

KHK-2866 Kyowa Hakko Kirin PharmaPrinceton, NJ

advanced solid tumors(see also ovarian) (609) 919-1100

(panobinostat)Novartis PharmaceuticalsEast Hanover, NJ

(see also kidney, leukemia, multiple myeloma, prostate) (888) 669-6682

(aldosterone synthase inhibitor)Novartis PharmaceuticalsEast Hanover, NJ (888) 669-6682

LCL161 Novartis PharmaceuticalsEast Hanover, NJ (888) 669-6682

(erismodegib)Novartis PharmaceuticalsEast Hanover, NJ

solid tumors (adults and pediatric)(see also leukemia, pancreatic, skin) (888) 669-6682

LDK378(ALK inhibitor)

Novartis PharmaceuticalsEast Hanover, NJ (888) 669-6682

LEE011 Novartis PharmaceuticalsEast Hanover, NJ

(see also lymphoma)(888) 669-6682

(Smo antagonist)Novartis PharmaceuticalsEast Hanover, NJ (888) 669-6682

L-MDAM BioNumerik Pharmaceuticals

(MTF-1 inhibitor)Lorus Therapeutics metastatic solid tumors

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

LP-261 Locus PharmaceuticalsBlue Bell, PA

lurbinectedin PharmaMarMadrid, Spain

(see also leukemia)www.pharmamar.com

(NADH oxidase inhibitor)Marshall EdwardsSan Diego, CA

refractory solid tumors

(anti-CEA BiTE)AstraZenecaWilmington, DE

Gaithersburg, MD

(800) 236-9933(301) 398-0000

AstraZenecaWilmington, DE

Gaithersburg, MD

(800) 236-9933(301) 398-0000

AstraZenecaWilmington, DE

Gaithersburg, MD

(800) 236-9933(301) 398-0000

(anti-ANG-2 mAb)AstraZenecaWilmington, DE

Gaithersburg, MD

(800) 236-9933(301) 398-0000

MG-1102 Green CrossYongin, South Korea

Mogam Biotechnology Research

Yongin, South Korea

second-line solid tumorswww.eng.greencross.com

MGA271 (anti-B7-H3)

MacroGenicsRockville, MD

refractory metastatic solid tumors

MGAH22 (anti-HER2 mAb) MacroGenicsRockville, MD

GenentechSouth San Francisco, CA

MerckWhitehouse Station, NJ (800) 672-6372

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

MerckWhitehouse Station, NJ

metastatic late-stage solid tumors(800) 672-6372

(PARP inhibitor)MerckWhitehouse Station, NJ (800) 672-6372

(aurora kinase A inhibitor)MerckWhitehouse Station, NJ

Vertex PharmaceuticalsCambridge, MA

(800) 672-6372

MerckWhitehouse Station, NJ

(see also leukemia)(800) 672-6372

MLN0128 Millennium PharmaceuticalsCambridge, MA

(see also other)

(tandutinib)Millennium PharmaceuticalsCambridge, MA

MLN1117 Millennium PharmaceuticalsCambridge, MA

(raf kinase inhibitor)Millennium PharmaceuticalsCambridge, MA

(NEDD8 inhibitor)Millennium PharmaceuticalsCambridge, MA

(see also other)

MLN8237(alisertib)

Millennium PharmaceuticalsCambridge, MA

(see also lymphoma)

MLN9708 (ixazomib)

Millennium PharmaceuticalsCambridge, MA

(see also lymphoma, multiple myeloma)

(EGFR antagonist)Merrimack PharmaceuticalsCambridge, MA

mocetinostat(MGCD0103, HDAC inhibitor)

MethylGeneMontreal, Canada

(see also leukemia, lymphoma)

MPDL-3280A GenentechSouth San Francisco, CA

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

(MEK inhibitor)EMD SeronoRockland, MA (800) 283-8088

MTKi-328 BeiGeneBeijing, China www.beigene.com

MTRN-2696 Spectrum PharmaceuticalsHenderson, NV

NKP-1339 Niiki PharmaHoboken, NJ

(pegylated docetaxel)Nektar TherapeuticsSan Francisco, CA

(CDC7 protein kinase inhibitor)Nerviano Medical ServicesNerviano, Italy www.nervianoms.com

NMS-1286937 Nerviano Medical ServicesNerviano, Italy www.nervianoms.com

(marizomib)Nereus PharmaceuticalsSan Diego, CA

(see also lymphoma, multiple myeloma)

olaparib(PARP inhibitor)

AstraZenecaWilmington, DE (800) 236-9933

Omapro™omacetaxine

CephalonFrazer, PA

(see also leukemia)

Bayer HealthCare PharmaceuticalsWayne, NJ

OncoMed PharmaceuticalsRedwood City, CA

OMP-21M18 GlaxoSmithKline

OncoMed PharmaceuticalsRedwood City, CA

(notch pathway)GlaxoSmithKline

OncoMed PharmaceuticalsRedwood City, CA

omtriptolide PharmagenesisRedwood City, CA

Pierre Fabre PharmaceuticalsParsippany, NJ

www.pierre-fabre.com

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

ONT-10(cancer vaccine)

OncothyreonSeattle, WA (206) 769-9219

ONX-0801 Onyx PharmaceuticalsSouth San Francisco, CA

Otsuka America PharmaceuticalRockville, MD

oprozomib Onyx PharmaceuticalsSouth San Francisco, CA

oral azacitidine CelgeneSummit, NJ

(see also leukemia, lung, lymphoma)(908) 673-9000

ortataxel Spectrum PharmaceuticalsHenderson, NV

taxane-refractory solid tumors

(c-kit/VEGFR-2) Farmingdale, NY (631) 962-0600

p28 peptide CDG TherapeuticsChicago, IL www.cdgti.com

paclitaxel liposomal Sun PharmaMumbai, India www.sunpharma.com

palifosfamideNew York, NY

(see also lung, sarcoma)

pbi-shRNA™ STMN1 LP

(anti-stathim gene therapy)Gradalis

perifosine AEterna ZentarisBasking Ridge, NJ

solid tumors (pediatric)(see also brain, colorectal, kidney, leukemia, lung, lymphoma, multiple myeloma, sarcoma, stomach)

PF-00337210(VEGFR2 antagonist) New York, NY

(ALK-1 mAb) New York, NY

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

New York, NY

New York, NY

(see also other)

New York, NY

(see also other)

Progen PharmaceuticalsQueensland, Australia

(see also lymphoma)www.progen-pharma.com

PLX3397(CSF-1R kinase inhibitor)

PlexxikonBerkeley, CA

metastatic solid tumors(see also brain, leukemia, lymphoma)

PharmaMarMadrid, Spain www.pharmamar.com

(bcl-2 oncogene inhibitor)ProNAi TherapeuticsAnn Arbor, MI

(CBP/catenin inhibitor) Yokohama, Japan www.prismbiolab.com

PRLX93936 Prolexys Pharmaceuticals

PTC299 PTC Therapeutics (see also breast, other)(908) 222-7000

purine nucleoside phosphorylasegene therapy

PNP TherapeuticsBirmingham, AL www.pnptherapeutics.com

Pathway TherapeuticsSan Francisco, CA www.pathwaytx.com

Quintessence BiosciencesMadison, WI

(raf kinase inhibitor)Novartis PharmaceuticalsEast Hanover, NJ

(see also skin)(888) 669-6682

Medicines in Development for Cancer

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Medicines in Development Cancer 2012106

SOLID TUMORS

Product Name Sponsor Indication Development Status

regorafenib Bayer HealthCare PharmaceuticalsWayne, NJ

(see also colorectal, kidney, lung, stomach)

Reolysin®

reovirusOncolytics BiotechCalgary, Canada

solid tumors (pediatric)(see also brain, colorectal, head/neck, lung, ovarian, pancreatic, sarcoma, skin)

RG7112(MDM2 antagonist)

RocheNutley, NJ

(see also other)

RG7116(ErbB-3 receptor antagonist)

Roche Nutley, NJ

(anti-CSF-1R mAb)RocheNutley, NJ

RG7167 RocheNutley, NJ

(MAP/raf inhibitor)RocheNutley, NJ

RG7321 GenentechSouth San Francisco, CA

RocheNutley, NJ

(NRP1 antagonist)GenentechSouth San Francisco, CA

RocheNutley, NJ

RocheNutley, NJ

RG7388(MDM2 inhibitor)

RocheNutley, NJ

(see also other)

(HFGR-1877S)GenentechSouth San Francisco, CA

(see also multiple myeloma)

(mAb)GenentechSouth San Francisco, CA

(mAb)GenentechSouth San Francisco, CA

advanced solid tumors

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

RG7602 GenentechSouth San Francisco, CA

(see also lymphoma)

robatumumab MerckWhitehouse Station, NJ

solid tumors (combination therapy)(see also colorectal, sarcoma)--------------------------------------------------solid tumors (pediatric)

(800) 672-6372-------------------------------------------

(800) 672-6372

RRx-001 RadioRxMountain View, CA

sapacitabine (CYC682)

Cyclacel PharmaceuticalsBerkeley Heights, NJ

(see also leukemia, lung)

(Met kinase inhibitor) Bridgewater, NJ

Bridgewater, NJ

combination therapyMerck SeronoGeneva, Switzerland

Bridgewater, NJ

combination therapy

inhibitor)

Merck SeronoGeneva, Switzerland

Bridgewater, NJ

(MM-121) companion diagnostic

Merrimack PharmaceuticalsCambridge, MA

Bridgewater, NJ

solid tumors (diagnosis)

(REGN910)(anti-Ang2 mAb)

Regeneron Pharmaceuticals

Bridgewater, NJ

(maytansin-loaded anti-DS6) Bridgewater, NJ

DS6-positive solid tumors

SB989 (pracinostat) Oakland, CA

late-stage solid tumors(see also leukemia, other)

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

MerckWhitehouse Station, NJ (800) 672-6372

seliciclib (CYC202)

Cyclacel PharmaceuticalsBerkeley Heights, NJ

(see also head/neck)

selumetinib

(MEK inhibitor)

AstraZenecaWilmington, DE (800) 236-9933

selumetinib

MK2206 combination (MEK/AKT inhibitor)

AstraZenecaWilmington, DE

MerckWhitehouse Station, NJ

(800) 236-9933(800) 672-6372

SF1126 Semafore PharmaceuticalsIndianapolis, IN

(see also leukemia, multiple myeloma)

Taxolog

solid tumor immunotherapy(mAb)

GenentechSouth San Francisco, CA

sonepcizumab LpathSan Diego, CA

(endothelin B receptor agonist)Spectrum PharmaceuticalsHenderson, NV

TAG vaccine Gradalis

(gonadotrophin hormone-releasing hormone receptor antagonist)

Millennium PharmaceuticalsCambridge, MA

(hedgehog signaling pathway inhibitor)

Millennium PharmaceuticalsCambridge, MA

TAK-701(HGF inhibitor)

Millennium PharmaceuticalsCambridge, MA

TAK-733(MEK inhibitor)

Millennium PharmaceuticalsCambridge, MA

Medicines in Development for Cancer

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SOLID TUMORS

Product Name Sponsor Indication Development Status

TAK-960(Plk1 inhibitor)

Millennium PharmaceuticalsCambridge, MA

teglarinad CephalonFrazer, PA

(see also lymphoma)

terameprocol Erimos Pharmaceuticals(see also brain, cervical, head/neck, other)

TKM-PLK1(RNAi)

Tekmira PharmaceuticalsBurnaby, Canada

(see also lymphoma)

TL-32711(birinapant)

TetraLogic PharmaceuticalsMalvern, PA

(see also leukemia)(610) 889-9900

TLC-388 TLC BiopharmaceuticalsSouth San Francisco, CA

TRC093 TRACON PharmaceuticalsSan Diego, CA

TRC102(DNA repair inhibitor)

TRACON PharmaceuticalsSan Diego, CA

tremelimumab AstraZenecaWilmington, DE

Gaithersburg, MD

(800) 236-9933(301) 398-0000

TST-10088 CangeneWinnipeg, Canada

(anti-HB-EGF antibody)Amgen

Daiichi Sankyo USParsippany, NJ

Drais PharmaceuticalsBridgewater, NJ

(see also lymphoma)

MerckWhitehouse Station, NJ (800) 672-6372

(telomerase inhibitor vaccine)GeronMenlo Park, CA

MerckWhitehouse Station, NJ

(800) 672-6372

Medicines in Development for Cancer

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Medicines in Development Cancer 2012110

SOLID TUMORS

Product Name Sponsor Indication Development Status

VGX-100(VEGF-C mAb)

Circadian TechnologiesVictoria, Australia www.circadian.com.au

VTX-2337 VentiRx PharmaceuticalsSeattle, WA

(see also lymphoma)

VaccinexRochester, NY

Munich, Germany www.wilex.de

X-82(dual VEGFR/PDGFR inhibitor)

TyrogenexWest Palm Beach, FL

advanced solid tumors

Xalkori®

crizotinib New York, NY

(see also lung)

XMT-1001 Mersana TherapeuticsCambridge, MA

XMT-1107 Mersana TherapeuticsCambridge, MA

STOMACH CANCER

Product Name Sponsor Indication Development Status

AT-101(oral pan Bcl-2 inhibitor)

Ascenta TherapeuticsMalvern, PA

late-stage esophageal cancer (combination therapy)(see also brain, leukemia, lung, lymphoma, prostate)

AT13387(Hsp90 inhibitor)

Astex PharmaceuticalsDublin, CA

late-stage gastrointestinal stromal

(see also solid tumors)

AUY922(Hsp90 inhibitor)

Novartis PharmaceuticalsEast Hanover, NJ (see also breast, colorectal, lung,

multiple myeloma)(888) 669-6682

Cambridge, MA (see also breast) (617) 679-2000

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 111

STOMACH CANCER

Product Name Sponsor Indication Development Status

crenolanib AROG Pharmaceuticals(see also brain)

EisaiWoodcliff Lake, NJ

gastric cancer (combination therapy)(see also brain, head/neck, liver, skin, solid tumors)

ERBITUX® cetuximab

Bristol-Myers SquibbPrinceton, NJ

Eli LillyIndianapolis, IN

gastric cancer(see also colorectal)

in clinical trials

ganetespib (Hsp90i)

Synta PharmaceuticalsLexington, MA

esophageal cancer, gastric cancer,

(see also breast, colorectal, leukemia, liver, lung, multiple myeloma, pancreatic, prostate, skin)

masitinib(Orphan Drug)

AB Science USAShort Hills, NJ (see also pancreatic)

Opaxio™paclitaxel poliglumex

Cell TherapeuticsSeattle, WA

esophageal cancer(see also brain, lung, ovarian, other)

perifosine AEterna ZentarisBasking Ridge, NJ (see also brain, colorectal, kidney,

leukemia, lung, lymphoma, multiple myeloma, sarcoma, solid tumors)

polyclonal antibody stimulator(Orphan Drug)

Cancer AdvancesDurham, NC

gastric cancer(see also colorectal, pancreatic) (919) 361-2162

ramucirumab Eli LillyIndianapolis, IN

Bridgewater, NJ

gastric cancer(see also breast, colorectal)

regorafenib(Orphan Drug)

Bayer HealthCare PharmaceuticalsWayne, NJ (see also colorectal, kidney, lung,

solid tumors)

S-1 Taiho Pharma U.S.A.Princeton, NJ

gastric cancer

Tasigna®nilotinib(Orphan Drug)

Novartis PharmaceuticalsEast Hanover, NJ (see also leukemia, skin) (888) 669-6682

Medicines in Development for Cancer

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Medicines in Development Cancer 2012112

STOMACH CANCER

Product Name Sponsor Indication Development Status

telatinib(Orphan Drug)

ACT BiotechSan Francisco, CA

gastric cancer (combination therapy)(see also colorectal)

tesetaxel(Orphan Drug)

GentaBerkeley Heights, NJ

gastric cancer(see also bladder, breast, prostate, skin)

(908) 286-9800

TNFerade™golnerminogene pradenovac

GenVecGaithersburg, MD

esophageal cancer(see also head/neck, prostate, skin)

trebananib (AMG386)

Amgen esophageal cancer, gastric cancer(see also breast, colorectal, kidney, liver, ovarian, other)

Tykerb®

lapatinibGlaxoSmithKline gastric cancer

(see also breast, head/neck)

uridine triacetate Gaithersburg, MD

gastric cancer(see also pancreatic)

Xeloda®

capecitabineGenentechSouth San Francisco, CA

esophageal cancer (see also brain, colorectal, liver)

CANCER/CHEMOTHERAPY-RELATED CONDITIONS

Product Name Sponsor Indication Development Status

AG103 ActoGenixZwijnaarde, Belgium

oral mucositis associated with cancertreatment www.actogenix.com

AP1903 Bellicum Pharmaceuticals graft-versus-host disease(see also prostate)

ARX-02 (sufentanil sublingual)

AcelRx PharmaceuticalsRedwood City, CA

breakthrough cancer pain

CA-18C3 XBiotech cancer-related cachexia(see also other, solid tumors)

Medicines in Development for Cancer

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CANCER/CHEMOTHERAPY-RELATED CONDITIONS

Product Name Sponsor Indication Development Status

(oltipraz)Canopus BioPharmaStudio City, CA

chemotherapy- and radiation-inducedmucositis www.canopusbiopharma.com

CLT-008 Cellerant TherapeuticsSan Carlos, CA

chemotherapy-related neutropenia(see also other)

dronabinol oral solutionPhoenix, AZ

chemotherapy-induced nausea and vomiting (602) 910-2617

EisaiWoodcliff Lake, NJ

oral mucositis

Emend®

aprepitantMerckWhitehouse Station, NJ

chemotherapy-induced nausea and vomiting (pediatric) (800) 672-6372

Emend® IV

aprepitantMerckWhitehouse Station, NJ

chemotherapy-induced nausea and vomiting (pediatric) (800) 672-6372

fentanyl inhalation Akela Pharma cancer pain

ferroportin mAb Eli LillyIndianapolis, IN

anemia associated with cancer

fulranumab Johnson & Johnson PharmaceuticalResearch & DevelopmentRaritan, NJ

cancer pain (adjunctive treatment)

hepcidin mAb Eli LillyIndianapolis, IN

anemia associated with cancer

LG631 LentigenGaithersburg, MD

chemoprotection in patients undergoing treatment for glioblastoma

mesenchymal stem cell therapy(Orphan Drug)

MesoblastNew York, NY

for bone marrow regeneration in patients undergoing bone marrow transplantation

(212) 880-2060

morphine intranasal Marina BiotechBothell, WA

cancer pain

MultiStem®

stem cell therapy(Orphan Drug)

Athersys Cleveland, OH

graft-versus-host disease in patients undergoing bone marrow transplant

Medicines in Development for Cancer

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CANCER/CHEMOTHERAPY-RELATED CONDITIONS

Product Name Sponsor Indication Development Status

nabiximols Otsuka America PharmaceuticalRockville, MD

cancer pain (adjunctive treatment)

netupitant/palonosetron Helsinn TherapeuticsBridgewater, NJ

chemotherapy-induced nausea and vomiting

NP-2 gene therapy(intradermal)

Diamyd MedicalPittsburgh, PA

cancer pain

Nplate®

romiplostimAmgen chemotherapy-associated

thrombocytopenia

PHY906 PhytoCeutica chemotherapy-induced gastrointestinal disorders(see also colorectal, liver, pancreatic)

Prochymal®

remestemcel-L(Orphan Drug)

Osiris TherapeuticsColumbia, MD

graft-versus-host disease

ProDermaCel™norepinephrine topical

ProCertus BioPharmMadison, WI

prevention of oral mucositis, prevention of radiation-induced skin damage

(608) 273-8862

Promacta®

eltrombopagGlaxoSmithKline chemotherapy-induced

thrombocytopenia (888) 669-6682

REGiMMUNESanta Clara, CA

graft-versus-host diseasewww.regimmune.com

rolapitant TESAROWaltham, MA

chemotherapy-induced nausea and vomiting (339) 970-0900

SGX201 SoligenixPrinceton, NJ

acute radiation enteritis in patients with cancer

sotatercept (ACE-011)

CelgeneSummit, NJ

chemotherapy-induced anemia(see also other) (908) 673-9000

tanezumabNew York, NY

cancer pain (adjunctive treatment)

Tavocept®

dimesnaBioNumerik Pharmaceuticals chemoprotection

(see also lung)

Medicines in Development for Cancer

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CANCER/CHEMOTHERAPY-RELATED CONDITIONS

Product Name Sponsor Indication Development Status

T-cell replacement therapy Bellicum Pharmaceuticals graft-versus-host disease in patients with late-stage cancer undergoing bone marrow transplantation

(Orphan Drug)

Kiadis PharmaAmsterdam, Netherlands

graft-versus-host diseasewww.kiadis.com

TXA127 Tarix PharmaceuticalsCambridge, MA

chemotherapy-induced thrombocytopenia www.tarixpharma.com

Velcade®

bortezomibMillennium PharmaceuticalsCambridge, MA

steroid-refractory graft-versus-host disease (see also leukemia, lymphoma, other)

XenomeQueensland, Australia

cancer painwww.xenome.com

Xgeva™denosumab

Amgen prevention of cancer-related bone damage or malignant hypercalcemia(see also multiple myeloma, other)

OTHER CANCERS

Product Name Sponsor Indication Development Status

United TherapeuticsSilver Spring, MD

peritoneal cancer(see also brain, sarcoma) (301) 608-9292

Å6 Angstrom PharmaceuticalsSolana Beach, CA

gynecologic cancer(see also ovarian)

(aurora kinase inhibitor)Abbott LaboratoriesAbbott Park, IL

hematological malignancies(see also solid tumors)

ABT-888 (veliparib)(PARP inhibitor)

Abbott LaboratoriesAbbott Park, IL

fallopian tube cancer(see also brain, breast, colorectal, lung, lymphoma, ovarian, prostate, skin)

AEZS-108 AEterna ZentarisBasking Ridge, NJ

late-stage endometrial cancer(see also bladder, ovarian, prostate)

AlloStim™Shoham, Israel

hematological malignancies(see also solid tumors) www.immunovative.co.il

Medicines in Development for Cancer

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Medicines in Development Cancer 2012116

OTHER CANCERS

Product Name Sponsor Indication Development Status

Alpharadin®

radium-223 chlorideBayer HealthCare PharmaceuticalsWayne, NJ

bone metastases from castration-resistant prostate cancer(see also solid tumors)

application submitted

ALT-801 Altor BioScienceMiramar, FL

urogenital cancer(see also skin)

AMG 319 Amgen hematological malignancies

AMG 900(aurora kinase inhibitor)

Amgen hematological malignancies(see also solid tumors)

anti-CD70 ADC Bristol-Myers SquibbPrinceton, NJ

hematological malignancies

Bristol-Myers SquibbPrinceton, NJ

hematological malignancies

ARQ 621 ArQuleWoburn, MA

hematological malignancies(see also solid tumors)

Avastin®

bevacizumabGenentechSouth San Francisco, CA

high-risk carcinoid tumor(see also brain, breast, colorectal, lung, ovarian)

BAY 10-02670 Bayer HealthCare PharmaceuticalsWayne, NJ

uterine leiomyoma

belinostat Spectrum PharmaceuticalsHenderson, NV

peritoneal cancer, thymoma(see also colorectal, leukemia, liver, lung, lymphoma, ovarian)--------------------------------------------------

--------------------------------------------------recurrent hematological malignancies(combination therapy)

-------------------------------------------

-------------------------------------------

BKM120 Novartis PharmaceuticalsEast Hanover, NJ

second-line endometrial cancer, second-line urogenital cancer(see also brain, breast, lung)

(888) 669-6682

BMN-673(PARP inhibitor)

BioMarin PharmaceuticalsNovato, CA

hematological malignancies

Medicines in Development for Cancer

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OTHER CANCERS

Product Name Sponsor Indication Development Status

BP-100-1-01 Bio-PathOgden, Utah

hematological malignancies

CA-18C3 XBiotech hematological malignancies(see also cancer-related, solid tumors)

cabozantinib

(Orphan Drug)

ExelixisSouth San Francisco, CA

medullary thyroid cancer(see also breast, kidney, lung, ovarian, prostate)

catumaxomab Fresenius Biotech North AmericaWaltham, MA

malignant ascites(see also ovarian) www.fresenius-biotech.com

CDX-1127 Celldex TherapeuticsNeedham, MA

hematological malignancies(see also solid tumors)

clodronic acid Bayer HealthCare PharmaceuticalsWayne, NJ

bone metastases

CLT-008 Cellerant TherapeuticsSan Carlos, CA

hematological malignancies(see also cancer-related)

(Orphan Drug)

Cornerstone PharmaceuticalsCranbury, NJ

hematological malignancies(see also pancreatic)

dalotuzumab MerckWhitehouse Station, NJ

neuroendocrine tumors(see also breast, lung, pancreatic) (800) 672-6372

GenentechSouth San Francisco, CA second-line peritoneal cancer

(see also ovarian)

(lapuleucel-T) dendritic cell vaccine

Dendreon Seattle, WA

high-risk, HER2-positive urogenitalcancer (adjuvant therapy)

E7080(lenvatinib)

EisaiWoodcliff Lake, NJ

thyroid cancer(see also brain, skin)--------------------------------------------------endometrial cancer

-------------------------------------------

(irofulven)EisaiWoodcliff Lake, NJ

thyroid cancer(see also ovarian, prostate)

efatutazone Daiichi SankyoParsippany, NJ

thyroid cancer(see also colorectal, lung)

Medicines in Development for Cancer

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OTHER CANCERS

Product Name Sponsor Indication Development Status

EGEN-001 EGENHuntsville, AL

fallopian tube cancer, peritoneal cancer(see also colorectal, ovarian)

elagolix Abbott LaboratoriesAbbott Park, IL

Neurocrine BiosciencesSan Diego, CA

uterine leiomyoma

ENMD-2076 EntreMedRockville, MD

late-stage cancer(see also multiple myeloma, ovarian)

Femara®

letrozoleNovartis PharmaceuticalsEast Hanover, NJ

recurrent, metastatic endometrial cancer (combination therapy) (888) 669-6682

folate binding protein (E39) vaccine

Galena BiopharmaLake Oswego, OR

endometrial cancer(see also breast, ovarian)

fostamatinib(SYK inhibitor)

AstraZenecaWilmington, DE

Rigel PharmaceuticalsSouth San Francisco, CA

hematological malignancies(800) 236-9933

Gleevec®

imatinibNovartis PharmaceuticalsEast Hanover, NJ (see also lung, prostate, skin) (888) 669-6682

Inlyta®

axitinib New York, NY

thyroid cancer(see also kidney, liver)

Cambridge, MA

hematological malignancies

Istodax®

romidepsinCelgeneSummit, NJ

hematological malignancies(see also kidney, pancreatic, prostate)

(908) 673-9000

IXEMPRA® ixabepilone

Bristol-Myers SquibbPrinceton, NJ

endometrial cancer in clinical trials

™ruxolitinib Wilmington, DE

hematological malignancies(see also pancreatic)

KaloBios PharmaceuticalsSouth San Francisco, CA

hematological malignancies

Marqibo®

vincristine liposomalTalon TherapeuticsSan Mateo, CA

pediatric cancers(see also leukemia, lymphoma, skin)

Medicines in Development for Cancer

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OTHER CANCERS

Product Name Sponsor Indication Development Status

(anti-CD19 mAb)AstraZenecaWilmington, DE

Gaithersburg, MD

hematological malignancies(800) 236-9933(301) 398-0000

MER-101 (zoledronic acid oral)

Merrion PharmaceuticalsWilmington, NC

bone metastaseswww/merrionpharma.com

Mirena®

levonorgestrel-releasingintrauterine system

Bayer HealthCare PharmaceuticalsWayne, PA

endometrial cancer, endometrial hyperplasia

(notch signaling pathwayinhibitor)

MerckWhitehouse Station, NJ

central nervous system (CNS) cancer in patients ages 3-21(see also breast)

(800) 672-6372

MK-2206(c-akt inhibitor)

Merck Whitehouse Station, NJ

inoperable/unresectable neuroendocrine tumors(see also breast)

(800) 672-6372

MLN0128 Millennium PharmaceuticalsCambridge, MA

hematological malignancies(see also solid tumors)

(NEDD8 inhibitor)Millennium PharmaceuticalsCambridge, MA

hematological malignancies(see aslo solid tumors)

motesanib Amgen thyroid cancer(see also breast, colorectal, lung)

moxetumomab pasudotox AstraZenecaWilmington, DE

Gaithersburg, MD

hematological malignancies(800) 236-9933(301) 398-0000

MSC1936369B EMD SeronoRockland, MA

hematological malignancies(800) 283-8088

Nexavar®

sorafenibBayer HealthCare PharmaceuticalsWayne, NJ

thyroid cancer(see also breast, colorectal, head/neck, kidney, leukemia, liver, lung, multiple myeloma, ovarian)--------------------------------------------------neuroendocrine tumors

-------------------------------------------

NiCord®

umbilical cord blood stem cell therapy

Gamida CellJerusalem, Israel

hematological malignancieswww.gamida-cell.com

Medicines in Development for Cancer

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OTHER CANCERS

Product Name Sponsor Indication Development Status

NTX-010 NeotropixMalvern, PA

neuroendocrine tumors(see also lung) www.neotropix.com

Opaxio™paclitaxel poliglumex

Cell TherapeuticsSeattle, WA

fallopian tube cancer, peritoneal cancer(see also brain, lung, ovarian, stomach)

OPR-003 EUSA PharmaLanghorne, PA

VaccinexRochester, NY

hematological malignancies

inhibitor)Farmingdale, NY

adrenocortical carcinoma(see also lung, ovarian) (631) 962-0600

PEG arginine deiminase Polaris PharmaceuticalsSan Diego, CA

pediatric cancer(see also liver, prostate, skin)

New York, NY

endometrial cancer(see also solid tumors)

New York, NY

endometrial cancer(see also solid tumors)

Nerviano Medical ServicesNerviano, Italy

thymoma www.nervianoms.com

phenoxodiol Marshall EdwardsSan Diego, CA

fallopian tube cancer (combination therapy)(see also ovarian, prostate)

PharmaMarMadrid, Spain

endometrial cancer(see also cervical, sarcoma) www.pharmamar.com

PTC299 PTC Therapeutics central nervous system (CNS) cancer in children(see also breast, solid tumors)

(908) 222-7000

RG7112(MDM2 antagonist)

RocheNutley, NJ

hematological malignancies(see also solid tumors)

RG7388(MDM2 inhibitor)

RocheNutley, NJ

hematological malignancies(see also solid tumors)

(mAb)RocheNutley, NJ

hematological malignancies

Medicines in Development for Cancer

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OTHER CANCERS

Product Name Sponsor Indication Development Status

(antibody drug conjugate)GenentechSouth San Francisco, CA

hematological malignancies

ridaforolimusCambridge, MA

MerckWhitehouse Station, NJ

endometrial cancer(see also breast, kidney, lung, prostate, sarcoma)

(800) 672-6372

rintatolimod Hemispherx BiopharmaPhiladelphia, PA

cancer vaccine adjuvant

injectionEUSA PharmaLanghorne, PA

bone metastases(see also breast, multiple myeloma, prostate, sarcoma)

(maytansin-loaded anti-CD19 mAb)

Bridgewater, NJ

Needham, MA

B-cell malignancies

Bridgewater, NJ

Exelixis South San Francisco, CA

endometrial cancer(see also breast)

(anti-CD38 naked mAb) Bridgewater, NJ

hematological malignancies

SB989 (pracinostat) Oakland, CA

hematological malignancies(see also leukemia, solid tumors)

siltuximab Janssen BiotechHorsham, PA

giant lymph node hyperplasia(see also multiple myeloma, prostate)

SOM230 (pasireotide)

Novartis PharmaceuticalsEast Hanover, NJ

carcinoid tumors

--------------------------------------------------meningioma, neuroendocrine tumors

(888) 669-6682-------------------------------------------

(888) 669-6682

sotatercept (ACE-011)

CelgeneSummit, NJ

cancer metastases(see also cancer-related) (908) 673-9000

SPRYCEL®

dasatinibBristol-Myers SquibbPrinceton, NJ

pediatric cancer(see also brain, breast, pancreatic, prostate)

in clinical trials

Medicines in Development for Cancer

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Medicines in Development Cancer 2012122

OTHER CANCERS

Product Name Sponsor Indication Development Status

StemEx®

carlecortemcel-L(Orphan Drug)

Gamida CellJerusalem, Israel

Teva North AmericaNorth Wales, PA

hematological malignancies(Fast Track) (888) 838-2872

TAK-901(aurora kinase B inhibitor)

Millennium PharmaceuticalsCambridge, MA

hematological malignancies

Tarceva®

erlotinibGenentechSouth San Francisco, CA

Farmingdale, NY

gynecological cancer (see also brain, breast, head/neck, leukemia, liver, lung) (631) 962-0600

telapristone Repros Therapeutics uterine leiomyoma

terameprocol Erimos Pharmaceuticals hematological malignancies (intravenous)(see also brain, cervical, head/neck, solid tumors)

TG02Oakland, CA

Tragara PharmaceuticalsSan Diego, CA

hematological malignancies

tivantinib (ARQ 197)

ArQuleWoburn, MA

Daiichi SankyoParsippany, NJ

germ cell and embryonal neoplasms(see also colorectal, kidney, liver, lung, pancreatic, sarcoma)

(dovitinib)Novartis PharmaceuticalsEast Hanover, NJ

second-line endometrial cancer, urothelial carcinoma(see also breast, kidney, multiple myeloma, prostate, skin)

(888) 669-6682

(ENG protein inhibitor)TRACON PharmaceuticalsSan Diego, CA

fallopian tube cancer, peritoneal cancer(see also breast, ovarian, prostate)

trebananib (AMG386) Amgen fallopian tube cancer, peritoneal cancer(see also breast, colorectal, kidney, liver, stomach)

Medicines in Development for Cancer

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OTHER CANCERS

Product Name Sponsor Indication Development Status

ulipristalParsippany, NJ

uterine leiomyoma

VB-111 VBL TherapeuticsOr Yehuda, Israel

thyroid cancer(see also brain) www.vblrx.com

Velcade®

bortezomibMillennium PharmaceuticalsCambridge, MA

adenocarcinoma (combination therapy)(see also leukemia, lymphoma, cancer-related)

volasertibPharmaceuticals

urogenital cancer

Votrient™pazopanib

GlaxoSmithKline fallopian tube cancer, peritoneal cancer(see also kidney, ovarian)

Xgeva™denosumab

Amgen prevention of bone metastases in men with castrate-resistant prostate cancer(see also cancer-related, multiple myeloma)--------------------------------------------------prevention of bone metastases in women with early-stage breast cancer--------------------------------------------------giant cell tumor of bone

application submitted

-------------------------------------------

-------------------------------------------

Zelboraf®

vemurafenibGenentechSouth San Francisco, CA

PlexxikonBerkeley, CA

inoperable/unresectable thyroid cancer(see also brain, colorectal)

Zolinza®

vorinostatMerckWhitehouse Station, NJ

gynecological cancer, peritoneal cancer(see also breast, leukemia, lung, lymphoma, multiple myeloma)

(800) 672-6273

Medicines in Development for Cancer

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UNSPECIFIED CANCER

Product Name Sponsor Indication Development Status

Apogee BiotechnologyHummelstown, PA

late-stage disease

(nab®

CelgeneSummit, NJ (908) 673-9000

AFX-9901 Afecta PharmaceuticalsIrvine, CA

in clinical trials

AGS-6MF AgensysSanta Monica, CA

Astellas Pharma US

AGS-16M8F AgensysSanta Monica, CA

Astellas Pharma US

ALT-836 Altor BioScienceMiramar, FL

Bristol-Myers SquibbPrinceton, NJ

anti-LAG3(BMS-986016)

Bristol-Myers SquibbPrinceton, NJ

(docetaxel for injectable emulsion)

ADVENTRX PharmaceuticalsSan Diego, CA

ARRY-300(MEK inhibitor)

Array BioPharmaBoulder, CO

Novartis PharmaceuticalsEast Hanover, NJ

(888) 669-6682

ARRY-382(c-fms antagonist)

Array BioPharmaBoulder, CO

CelgeneSummit, NJ

metastatic cancer

(908) 673-9000

AVL-292(Btk inhibitor)

CelgeneSummit, NJ

(see also leukemia, lymphoma)(908) 673-9000

B7-2/GM-CSFcancer gene therapy vaccine

NuVax Therapeutics

(PET imaging)Bayer HealthCare PharmaceuticalsWayne, NJ

cancer (diagnosis)

Medicines in Development for Cancer

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UNSPECIFIED CANCER

Product Name Sponsor Indication Development Status

cancer vaccineVancouver, Canada www.immunitor.com

cancer vaccine Cytokine PharmaSciencesKing of Prussia, PA (610) 687-1776

carboxyamidotriazole orotate(CTO)

Tactical TherapeuticsNew York, NY

Cleveland BioLabsBuffalo, NY

Eli LillyIndianapolis, IN

CDX-301(Fms-like tyrosine kinase 3 ligand)

Celldex TherapeuticsNeedham, MA

cell therapy Cell MedicaLondon, United Kingdom

Center for Cell and Gene Therapywww.cellmedica.co.uk

CEN-109 Centella TherapeuticsPalo Alto, CA

cancer (diagnosis)www.centellatx.com

Chk1 inhibitor Eli LillyIndianapolis, IN

c-Met inhibitor Eli LillyIndianapolis, IN

c-Met mAb Eli LillyIndianapolis, IN

CSF-1R mAb Eli LillyIndianapolis, IN

Bridgewater, NJ

curmucin Signpath PharmaQuakertown, PA (267) 772-0107

Eli LillyIndianapolis, IN

Medicines in Development for Cancer

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UNSPECIFIED CANCER

Product Name Sponsor Indication Development Status

cytotropic heterogeneous molecular lipids(CHML)

Glory PharmaceuticalsVienna, VA

DM-CHOC-PEN Dekk-TecNew Orleans, LA

EndocyteWest Lafayette, IN www.endocyte.com

Bristol-Myers SquibbPrinceton, NJ

Eli LillyIndianapolis, IN

fenretinide intravenous CerRxwww.cerrx.com

FGF receptor inhibitor Eli LillyIndianapolis, IN

ACEA BiosciencesSan Diego, CA (866) 308-2232

gemcitabine prodrug Eli LillyIndianapolis, IN

(cancer vaccine) Louisville, CO

GSK3 inhibitor Eli LillyIndianapolis, IN

San Diego, CA

Quintileswww.huyabio.com

hedgehog antagonist Eli LillyIndianapolis, IN

hTERT plasmid DNA cancer vaccine

MerckWhitehouse Station, NJ

VicalSan Diego, CA

(800) 672-6372

Medicines in Development for Cancer

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UNSPECIFIED CANCER

Product Name Sponsor Indication Development Status

Bristol-Myers SquibbPrinceton, NJ

imaging agentMayo ClinicRochester, MN

NaviscanSan Diego, CA

cancer (diagnosis)www.mayoclinic.org

RxCarlsbad, CA

JAK2 inhibitor Eli LillyIndianapolis, IN

masoprocol TriAct TherapeuticsSan Francisco, CA

MK-8033(c-Met/RON protein inhibitor)

MerckWhitehouse Station, NJ (800) 672-6372

new molecular entity Eli LillyIndianapolis, IN

notch inhibitor Eli LillyIndianapolis, IN

notch inhibitor Bristol-Myers SquibbPrinceton, NJ

OPB-31121 Otsuka America PharmaceuticalRockville, MD

p38 MAP inhibitor (1) Eli LillyIndianapolis, IN

p38 MAP inhibitor (2) Eli LillyIndianapolis, IN

p70/AKT inhibitor Eli LillyIndianapolis, IN

Puma BiotechnologyLos Angeles, CA

Medicines in Development for Cancer

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Medicines in Development Cancer 2012128

UNSPECIFIED CANCER

Product Name Sponsor Indication Development Status

Phoenix Biotechnology

New York, NY

PD-0332991New York, NY

(gamma-secretase inhibitor) New York, NY

(sonic hedgehog pathway inhibitor)

New York, NY

(CD137 antigen agonist mAb) New York, NY

Proleukin®

aldesleukin(subcutaneous)

Prometheus LaboratoriesSan Diego, CA

(888) 892-8391

PRT6207Cambridge, MA

Portola PharmaceuticalsSouth San Francisco, CA

RON mAb Eli LillyIndianapolis, IN

Bridgewater, NJ

(JAK2 inhibitor) Oakland, CA

SCH-900776 MerckWhitehouse Station, NJ (800) 672-6372

SMO antagonist (BMS-833923)

Bristol-Myers SquibbPrinceton, NJ

SR13668Menlo Park, CA

cancer (prevention) Phase 0

V930/V932(plasmid DNA vaccine)

MerckWhitehouse Station, NJ

VicalSan Diego, CA

(800) 672-6372

Medicines in Development for Cancer

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Medicines in Development Cancer 2012 129

UNSPECIFIED CANCER

Product Name Sponsor Indication Development Status

VEGFR3 mAb Eli LillyIndianapolis, IN

Bridgewater, NJ

XmAb® anti-cancer mAb Pharmaceuticals

XencorMonrovia, CA

Medicines in Development for Cancer

Report

current as of May 16, 2012. -

A publication of PhRMA’s Communications & Public Affairs Department. (202) 835-3460

www.phrma.org | www.innovation.org | www.pparx.org | www.buysafedrugs.info

Copyright © 2012 by the Pharmaceutical Research and Manufacturers of America. Permission to reprint is awarded if proper credit is given.

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Glossary

actinic keratoses—Roughness and thicken-ing of the skin caused by overexposure to the

skin cancer called squamous cell carcinoma.

adenocarcinoma—Malignant tumor derived from a gland or glandular tissue.

adjunctive treatment—An auxiliary treatment that is secondary to the main treatment.

adjuvant—A substance or drug that aids another substance in its action.

allogeneic—Refers to having cell types that are distinct and cause reactions in the immune system.

application submitted—An application for marketing has been submitted by the company to the Food and Drug Administration (FDA).

ascites

the tissues lining the abdomen and abdominal organs (the peritoneal cavity).

basal cell cancer—Cancer of the lower layers of the skin.

B-cell—A class of white blood cells important to the body’s immune system.

biliary—Relating to bile.

carcinoma—A malignant tumor that arises from epithelial tissues, such as skin.

cervical—Relating to the neck of the uterus.

chemoprotection—A therapeutic technique in which bone marrow cells are removed from an individual with cancer and are genetically modi-

before being returned to the donor.

cholangiocarcinoma—A malignancy of the biliary duct system that may originate in the liver and extrahepatic bile ducts. More than 90 percent are adenocarcinomas, and the remain-der are squamous cell tumors. Cholangiocarci-

walls of the ducts. Each year, approximately

is 1 case per 100,000 people per year.

cutaneous—Pertaining to the skin.

dysplasia—Abnormal tissue development.

gastric—Of or relating to the stomach.

GIST

Although these cancers can arise anywhere

stomach (60% to 70%) and less commonly in the small intestine (20% to 30%). The rest are found in the esophagus, large intestine, rectum, and anus. About 80% of people diag-

more common in men. Blacks are more likely

glioblastoma—A fast growing and highly malignant type of brain tumor arising from glial (supporting) cells within the brain. There are

-tion per year in the United States.

glioma—A type of brain tumor arising from the supporting glial cells within the brain. Gliomas make up about 60 percent of all primary brain tumors and are frequently malignant.

graft-versus-host disease (GVHD)—A complication in bone marrow transplants where immune system cells attack the transplant recipient’s tissues.

head and neck cancer—The term given to a variety of malignant tumors that develop in the mouth, throat, paranasal sinuses, nasal cavity, larynx, and salivary glands. Many authorities also include skin tumors of the face and neck and tumors of the cervical lymph nodes. There are more than half a million survivors of oral, head, and neck cancer living in the United States today.

hematological malignancies—Cancers of the blood or blood-forming tissues, such as leuke-

mia, Hodgkin’s and non-Hodgkin’s lympho-

mas multiple

myeloma, myelodysplasia and myeloprolifera-tive disorders.

hepatocellular cancer/carcinoma—A cancer that begins in the liver cells.

hyperuricemia—An abnormally high uric acid level in the blood.

imaging agent—A substance used to enhance x-ray images of organs and spaces in the body.

intraepithelial neoplasia, anal (AIN) & cervi-

cal (CIN)

human papillomavirus infection in the anal canal and appears to be driven by high viral

of its natural history resembles that of cervical intraepithelial neoplasia. Dysplasia and cervi-

terms or names for the same condition—it is a precursor to cervical cancer

mild, moderate or severe.

Kaposi’s sarcoma—A rare, malignant skin

can be accompanied by fever, enlarged lymph nodes and gastrointestinal problems.

Leiomyoma—A benign neoplasm derived from smooth muscle.

leukemia—A form of cancer in which abnor-mally growing white blood cells are scattered throughout the body and bone marrow. They can take over the marrow and prevent it from making enough normal blood cells (white, red and platelets), leaving the patient highly susceptible to serious infections, anemia and bleeding episodes. The cells can also spill into

function of other organs. The four main types acute lympho blastic leuke-

mia (ALL), acute myeloid leukemia (AML),

chronic lymphocytic leukemia (CLL), and chronic myeloid leukemia (CML). The acute types have a rapid onset, and overwhelming infection or blood loss can cause death. The chronic forms progress much more slowly.

lung cancer—The leading cause of cancer deaths in both men and women. There are several types of lung cancer, the most common being squamous cell carcinoma, small (oat) cell carcinoma, adenocarcinoma and large cell

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Medicines in Development Cancer 2012 131

Glossary

carcinoma. Each has a different growth pattern and response to treatment. The squamous cell, small cell and large cell types are all strongly associated with tobacco abuse.

lymphoma—Cancers in which the cells of lym-phoid tissue, found mainly in the lymph nodes and spleen, multiply unchecked. Lymphomas

-acterized by a particular kind of abnormal cell, and non-Hodgkin lymphomas, which vary in their malignancy according to the nature and activity of the abnormal cells. Mantle cell lym-

phoma is a type of non-Hodgkin lymphoma.

macroglobulinemia—A disorder in which plasma cells produce an excessive quantity of macroglobulins (large antibodies) that ac-

of abnormal, cancerous lymphocytes and plasma cells. Men are affected more often than

mastocytosis—A condition characterized by

body. Mast cells are connective tissue cells which release chemicals including histamine that are very irritating and cause itching, swell-

medullary—Relating to the medulla (any soft marrow-like structure, especially the innermost part) or marrow.

melanoma—A cancer made up of pigmented (usually brown-colored) skin cells anywhere in the body.

mesothelioma—A tumor of the lining of the lung and chest cavity (the pleura).

metastases/metastatic—Areas of secondary cancer that have spread from the primary or original cancer site.

mucositis—The swelling, irritation, and ulcer-ation of the mucosal cells that line the digestive tract. Mucositis can occur anywhere along the

can be a very troublesome and painful side effect of chemotherapy.

multiple myeloma—A malignant condition of middle to old age, characterized by the uncon-trolled proliferation and disordered function of plasma cells in the bone marrow. The condi-tion, which makes the patient particularly prone to infection, is rare, with about three new cases annually per 100,000 population.

myeloablation—A severe form of myelosup-pression, a condition in which bone marrow activity is decreased, resulting in fewer red

a side effect of some cancer treatments.

myelodysplastic syndromes (MDS)—Blood disorders that ultimately are fatal. Patients usually succumb to infections or bleeding. The term “preleukemia” has been used to describe these disorders.

neoadjuvant therapy—Chemotherapy, radia-tion therapy, or hormone therapy given before the primary or main treatment. Neo-adjuvant therapy, like chemotherapy and radiation therapy, is often given before surgery to reduce the size of a tumor or to make surgery less complicated.

neuroblastoma—A tumor of the adrenal glands or sympathetic nervous system (the part of the nervous system responsible for certain automatic body functions, such as the control of heart rate). Neuroblastomas are the most common extracranial (outside the skull) solid tumors of childhood.

osteosarcoma—Cancer of the bone that oc-curs predominantly in adolescents and young

children.

peritoneal—Relating to the peritoneum, the membrane that lines the abdominal cavity and covers most of the abdominal organs.

Phase 0—First-in-human trials conducted in accordance with FDA’s 2006 guidance on

studies designed to speed up development of promising drugs by establishing very early on whether the agent behaves in human subjects as was anticipated from preclinical studies.

Phase I—Safety testing and pharmacologi-

humans.

Phase II -tion of side effects of new drugs in humans.

Phase III—Extensive clinical trials in humans to verify effectiveness and monitor adverse reactions of new drugs.

prolactinoma—A noncancerous pituitary tumor that produces a hormone called prolac-tin, which results in too much prolactin in the blood.

refractory—Resistant to treatment or cure.

sarcoma—A malignant tumor that arises from deep body tissues, such as muscle, bone or

T-cell—One of two main classes of white blood cells called lymphocytes, which are important

thrombocytopenia—A reduction in the number of platelet cells in the blood, which causes a tendency to bleed, especially from the smaller blood vessels.

thymoma—Although rare, thymomas are the most common tumor of the thymus, a small organ located in the upper chest just below the neck that produces certain types of white blood cells (lymphocytes) before birth and during childhood. Thymomas arise from thymic epithelial cells, which make up the covering of

invasive. They affect men and women equally and are usually diagnosed between the ages

children.

unresectable—Unable to be removed (re-sected) by surgery.

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Medicines in Development Cancer 2012132

Selected Facts about Cancer in the United States

-ity, and poor nutrition, and thus could be prevented.

Studies have shown that pain occurs in 30 percent of all cancer patients, regardless of the stage of the disease, and 90 percent of patients with advanced cancer experience severe pain. Half of patients may be undertreated for cancer pain.2

The most common cause of cancer-related pain is from metastases to the bone. Up to 80 percent of cancer patients with bone metastases

structures may cause the most severe pain. The third most common cause of pain associated with cancer result from chemotherapy, radiation, or surgery.2

Breakthrough pain—pain that occurs even when taking regular pain medication—is common in cancer patients. Breakthrough cancer pain

-

3

Overview1

Pain

Costs1

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Medicines in Development Cancer 2012 133

New Cancer Cases/Deaths1

Cancer Type Estimated 2012 New Cases Estimated 2012 Deaths

All Sites .................................................................................. 1,638,910 ..................................................................................... Male ............................................................................. ..................................................................................... 301,820 Female ......................................................................... .....................................................................................

Acute Lymphocytic Leukemia .......................................................... ......................................................................................... Male ................................................................................. ............................................................................................ 820 Female ............................................................................. 2,600 ............................................................................................ 620

Acute Myeloid Leukemia ............................................................... 13,780 ....................................................................................... 10,200 Male ................................................................................. ......................................................................................... Female ............................................................................. .........................................................................................

Bladder Cancer .............................................................................. ....................................................................................... Male ............................................................................... ....................................................................................... Female ........................................................................... 17,910 .........................................................................................

Bone Cancer (and joints) ................................................................. 2,890 ......................................................................................... Male ................................................................................. 1,600 ............................................................................................ 790 Female ............................................................................. 1,290 ............................................................................................ 620

Brain Cancer (and other nervous system) ..................................... 22,910 ....................................................................................... 13,700 Male ............................................................................... 12,630 ......................................................................................... 7,720 Female ........................................................................... 10,280 .........................................................................................

Breast Cancer .............................................................................. 229,060 ....................................................................................... 39,920 Male ................................................................................. 2,190 ............................................................................................ Female ......................................................................... 226,870 .......................................................................................

Cervical and Uterine Cancers ........................................................ ....................................................................................... 12,230 Male .......................................................................................— ...............................................................................................— Female ........................................................................... ....................................................................................... 12,230

Chronic Lymphocytic Leukemia ..................................................... 16,060 ......................................................................................... Male ................................................................................. ......................................................................................... 2,730 Female ............................................................................. .........................................................................................

Chronic Myeloid Leukemia .............................................................. ............................................................................................ 610 Male ................................................................................. 3,210 ............................................................................................ 370 Female ............................................................................. 2,220 ............................................................................................

Colorectal Cancer ........................................................................ ....................................................................................... Male ............................................................................... ....................................................................................... Female ........................................................................... .......................................................................................

Selected Facts about Cancer in the United States

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Medicines in Development Cancer 2012134

Selected Facts about Cancer in the United States

Cancer Type Estimated 2012 New Cases Estimated 2012 Deaths

Esophageal Cancer ....................................................................... ....................................................................................... Male ............................................................................... ....................................................................................... Female ............................................................................. ......................................................................................... 3,030

Kidney Cancer (and renal pelvis) .................................................. ....................................................................................... Male ............................................................................... ......................................................................................... Female ........................................................................... .........................................................................................

Leukemia (all types) ...................................................................... ....................................................................................... Male ............................................................................... 26,830 ....................................................................................... Female ........................................................................... 20,320 .......................................................................................

Liver Cancer .................................................................................. 28,720 ....................................................................................... Male ............................................................................... 21,370 ....................................................................................... 13,980 Female ............................................................................. .........................................................................................

Lung Cancer (and bronchus) ....................................................... 226,160 ..................................................................................... Male .............................................................................. ....................................................................................... Female ......................................................................... 109,690 .......................................................................................

Lymphoma (all types) .................................................................... 79,190 ....................................................................................... 20,130 Male ............................................................................... ....................................................................................... 10,990 Female ........................................................................... 36,070 .........................................................................................

Lymphoma (non-Hodgkin’s) ........................................................... 70,130 ....................................................................................... Male ............................................................................... 38,160 ....................................................................................... 10,320 Female ........................................................................... 31,970 ......................................................................................... 8,620

Melanoma-Skin Cancer ................................................................. ......................................................................................... 9,180 Male ............................................................................... ......................................................................................... 6,060 Female ........................................................................... 32,000 ......................................................................................... 3,120

Multiple Myeloma ........................................................................... 21,700 ....................................................................................... 10,710 Male ............................................................................... 12,190 ......................................................................................... 6,020 Female ............................................................................. .........................................................................................

Ovarian Cancer ............................................................................. 22,280 ....................................................................................... Male .......................................................................................— ...............................................................................................— Female ........................................................................... 22,280 .......................................................................................

Pancreatic Cancer ......................................................................... ....................................................................................... 37,390 Male ............................................................................... 22,090 ....................................................................................... Female ........................................................................... 21,830 .......................................................................................

New Cancer Cases/Deaths1 continued

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Medicines in Development Cancer 2012 135

Selected Facts about Cancer in the United States

New Cancer Cases/Deaths1 continued

Sources:

1. American Cancer Society (www.cancer.org)

2. Remedy Health Media, LLC (www.healthcommunities.com)

3. American Pain Foundation (www.painfoundation.org)

Cancer Type Estimated 2012 New Cases Estimated 2012 Deaths

Prostate Cancer ........................................................................... ....................................................................................... 28,170 Male ............................................................................. ....................................................................................... 28,170 Female ...................................................................................— ...............................................................................................—

Stomach Cancer ............................................................................ 21,320 ....................................................................................... Male ............................................................................... 13,020 ......................................................................................... 6,190 Female ............................................................................. 8,300 .........................................................................................

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The U.S. system of new drug approvals is

perhaps the most rigorous in the world.

experimental drug to travel from lab to U.S. patients, according to the Tufts Center for the

compounds that enter preclinical testing make

is approved for sale.

including the cost of failures, to get one new medicine from the laboratory to U.S. patients, according to a 2007 study by the Tufts Center for the Study of Drug Development.

the laboratory, medicines are usually devel-

Preclinical Testing. A pharmaceutical com-pany conducts laboratory and animal studies to show biological activity of the compound against the targeted disease, and the com-pound is evaluated for safety.

Investigational New Drug Application (IND). After completing preclinical testing, a company

Administration (FDA) to begin to test the drug

is manufactured. All clinical trials must be

conducted. Progress reports on clinical trials must be submitted at least annually to FDA and

Clinical Trials, Phase I. These tests usually involve about 20 to 100 healthy volunteers. The

safe dosage range. The studies also determine how a drug is absorbed, distributed, metabo-lized, and excreted as well as the duration of its action.

Clinical Trials, Phase II.

volunteer patients (people with the disease) assess a drug’s effectiveness and determine

Clinical Trials, Phase III. This phase usually

hospitals. Physicians monitor patients closely to

New Drug Application (NDA)/Biologic

License Application (BLA). Following the completion of all three phases of clinical trials,

NDA or BLA with FDA if the data successfully demonstrate both safety and effectiveness.

information that the company has gathered. Applications typically run 100,000 pages or more.

Approval. Once FDA approves an NDA or BLA, the new medicine becomes available for physicians to prescribe. A company must continue to submit periodic reports to FDA, including any cases of adverse reactions and appropriate quality-control records. For some medicines, FDA requires additional trials

Discovering and developing safe and effective

process. PhRMA member companies invested

development in 2011.

The Drug Discovery, Development and Approval Process

Developing a new medicine takes an average of 10-15 years;

For every 5,000-10,000 compounds in the pipeline, only 1 is approved.

The Drug Development and Approval Process


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