2005 Cancer M E D I C I N E S I N D E V E L O P M E N T F O R Survey P R E S E N T E D B Y A M E R I C A ’ S B I O P H A R M A C E U T I C A L C O M P A N I E S T here are few things that cause patients more fear and uncertainty as a cancer diagnosis. Yet today— because of a steady stream of new and improved medicines and treatments—cancer can increasingly be managed and even beaten. Patients and their families are looking for even more and better treatments, and America’s research biopharmaceutical companies are responding. Biopharmaceutical researchers are working on 399 medicines for cancer. Many are high-tech weapons that fight the disease in new ways, while some involve research on new ways to use existing medicines. The research is being conducted by 178 pharmaceutical and biotechnology companies and by the National Cancer Institute. The medicines in development—all in either clinical trials or under Food and Drug Administration review— include 62 for lung cancer, the leading cause of cancer death in the United States; 49 for breast cancer, which is expected to strike more than 200,000 American women this year; 35 for colon cancer, the third most common cancer in both men and women in this country; and 50 for prostate cancer, which this year is expected to kill more than 30,000 American men. Additional medicines target kidney cancer, pancreatic cancer, brain cancer, skin cancer, ovarian cancer, and others. In addition, companies are working on medicines to improve the quality of life for people undergoing cancer treatment. This commitment to patients and research promises to continue and accelerate the remarkable progress made in the past decade against cancer, which led to declines in both cancer cases and cancer deaths. Death rates for eight of the top 10 cancers remained level or declined during the 1990s, according to a Journal of the National Cancer Institute report. Research-based pharmaceutical and biotechnology companies have made progress by bringing cutting-edge new cancer treatments to patients. For example: • A breakthrough medicine to treat metastatic colorectal cancer is the first treatment approved to prevent the formation of new blood vessels that provide tumors with oxygen and nutrients—a process known as angiogenesis. • A medicine for the treatment of non-small-cell lung cancer inhibits the formation and growth of tumor cells. • The first in a new class of drugs prevents acute and delayed nausea and vomiting associated with chemotherapy. Many of the new medicines in the pipeline also use new approaches and technologies to fight cancer. They include: • A medicine that targets a protein that may interfere with the effectiveness of chemotherapy. • A drug that delivers a synthetic version of a substance derived from scorpions directly to brain tumor cells. • A medicine designed to induce a powerful immune response to melanoma. Despite the progress, cancer remains the second leading cause of death by disease in the United States, exceeded only by heart disease. This year, some 570,280 Americans are expected to die of cancer—more than 1,500 people a day. The hundreds of new medicines to treat cancer now being developed by the research biopharmaceutical industry demonstrate our commitment to meeting patient needs as well as our best hope for stemming the toll of cancer-related deaths. Billy Tauzin President and CEO PhRMA 399 Medicines in Development Offer Hope in the War on Cancer MEDICINES IN D EVELOPMENT FOR C ANCER * *Some medicines are listed in more than one category. Unspecified Cancers Other Cancers Cancer-Related Conditions Stomach Cancer Solid Tumors Skin Cancer Sarcoma Prostate Cancer Pancreatic Cancer Ovarian Cancer Neuroblastoma Multiple Myeloma Lymphoma Lung Cancer Liver Cancer Leukemia Kidney Cancer Head/Neck Cancer Colon Cancer Cervical Cancer Breast Cancer Brain Cancer Bladder Cancer 6 25 49 13 35 15 26 52 13 62 51 20 3 21 25 50 8 39 85 15 24 24 25
Transcript
2005
CancerM E D I C I N E S I N D E V E L O P M E N T F O R
Survey
P R E S E N T E D B Y A M E R I C A ’ S B I O P H A R M A C E U T I C A L C O M P A N I E S
There are few things that cause patients more fear anduncertainty as a cancer diagnosis. Yet today—because of a steady stream of new and improved
medicines and treatments—cancer can increasingly bemanaged and even beaten. Patients and their families arelooking for even more and better treatments, and America’sresearch biopharmaceutical companies are responding.
Biopharmaceutical researchers are working on 399medicines for cancer. Many are high-tech weapons thatfight the disease in new ways, while some involveresearch on new ways to use existing medicines. Theresearch is being conducted by 178 pharmaceutical and biotechnology companies and by the NationalCancer Institute.
The medicines in development—all in either clinicaltrials or under Food and Drug Administration review—include 62 for lung cancer, the leading cause of cancerdeath in the United States; 49 for breast cancer, which isexpected to strike more than 200,000 American womenthis year; 35 for colon cancer, the third most commoncancer in both men and women in this country; and 50 forprostate cancer, which this year is expected to kill morethan 30,000 American men. Additional medicines targetkidney cancer, pancreatic cancer, brain cancer, skin cancer,ovarian cancer, and others. In addition, companies areworking on medicines to improve the quality of life forpeople undergoing cancer treatment.
This commitment to patients and research promises tocontinue and accelerate the remarkable progress made inthe past decade against cancer, which led to declines inboth cancer cases and cancer deaths. Death rates for eightof the top 10 cancers remained level or declined duringthe 1990s, according to a Journal of the National CancerInstitute report.
Research-based pharmaceutical and biotechnologycompanies have made progress by bringing cutting-edgenew cancer treatments to patients. For example:
• A breakthrough medicine to treat metastatic colorectalcancer is the first treatment approved to prevent theformation of new blood vessels that provide tumorswith oxygen and nutrients—a process known asangiogenesis.
• A medicine for the treatment of non-small-cell lungcancer inhibits the formation and growth of tumorcells.
• The first in a new class of drugs prevents acute anddelayed nausea and vomiting associated withchemotherapy.
Many of the new medicines in the pipeline also use newapproaches and technologies to fight cancer. They include:
• A medicine that targets a protein that may interferewith the effectiveness of chemotherapy.
• A drug that delivers a synthetic version of a substancederived from scorpions directly to brain tumor cells.
• A medicine designed to induce a powerful immuneresponse to melanoma.
Despite the progress, cancer remains the second leadingcause of death by disease in the United States, exceededonly by heart disease. This year, some 570,280 Americansare expected to die of cancer—more than 1,500 people aday. The hundreds of new medicines to treat cancer nowbeing developed by the research biopharmaceuticalindustry demonstrate our commitment to meeting patientneeds as well as our best hope for stemming the toll ofcancer-related deaths.
Billy TauzinPresident and CEOPhRMA
399 Medicines in Development OfferHope in the War on Cancer
MEDICINES IN DEVELOPMENT FOR CANCER*
*Some medicines are l is ted in more than one category.
Unspecified CancersOther Cancers
Cancer-Related ConditionsStomach Cancer
Solid TumorsSkin Cancer
SarcomaProstate Cancer
Pancreatic CancerOvarian CancerNeuroblastoma
Multiple MyelomaLymphoma
Lung CancerLiver Cancer
LeukemiaKidney Cancer
Head/Neck CancerColon Cancer
Cervical CancerBreast CancerBrain Cancer
Bladder Cancer 625
4913
3515
2652
1362
5120
321
2550
839
8515
242425
2 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
Medicines in Development for CancerB L A D D E R C A N C E RProduct Name Sponsor Indication Development Status*
BCI Immune Intracel Resources superficial bladder cancer or Phase IIIActivator Frederick, MD carcinoma in situ (CIS) in patients (301) 668-8400modified keyhole refractory to BCG treatmentlimpet hemocyanin (KLH)
depsipeptide National Cancer Institute (see also brain, colon, head/neck, Phase II(FK228) Bethesda, MD leukemia, lung, lymphoma, N C I T R I A L
Gloucester ovarian, skin, solid tumors, (800) 4-CANCERPharmaceuticals stomach, other)Cambridge, MA
EOquin Spectrum Pharmaceuticals superficial bladder cancer Phase IIIrvine, CA (radiation sensitizer) (949) 788-6700
lapatinib GlaxoSmithKline (see also breast, head/neck, Phase III(ErbB-2 and EGFR Philadelphia, PA kidney, lung, stomach) (888) 825-5249dual kinase Rsch. Triangle Park, NCinhibitor)
Proxinium™ Viventia Biotech (see also head/neck) Phase IToronto, Ontario (416) 291-1277
vinflunine Bristol-Myers Squibb (see also lung) Phase IIIPrinceton, NJ (212) 546-4000
B R A I N C A N C E RProduct Name Sponsor Indication Development Status131I-TM-601 TransMolecular recurrent glioma Phase II(Orphan Drug) Birmingham, AL (205) 972-0770
AP23573 ARIAD Pharmaceuticals glioblastoma Phase I(mTOR inhibitor) Cambridge, MA (see also cervical, leukemia, (617) 494-0400
fenretinide National Cancer Institute glioblastoma Phase II(4-HPR) Bethesda, MD (see also prostate, solid tumors) N C I T R I A L
(800) 4-CANCER
GW572016 National Cancer Institute (see also breast, cervical, Phase I/IIBethesda, MD head/neck, liver, prostate, stomach) N C I T R I A L
GlaxoSmithKline (800) 4-CANCERPhiladelphia, PARsch. Triangle Park, NC
Hemopure® Biopure treatment of patients with Phase Ihemoglobin Cambridge, MA glioblastoma as an adjunct to (617) 234-6500glutamer-250 radiotherapy by increasing oxygen (bovine) perfusion in hypoxic tumors
Hycamtin® National Cancer Institute (see also lung, ovarian) Phase IItopotecan Bethesda, MD N C I T R I A L
GlaxoSmithKline (800) 4-CANCERPhiladelphia, PARsch. Triangle Park, NC
irofulven MGI Pharma recurrent malignant glioma Phase IIMinneapolis, MN (see also liver, ovarian, prostate) (952) 346-4700
4 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
B R A I N C A N C E RProduct Name Sponsor Indication Development Status
MPC-6827 Myriad Genetics metastatic brain cancer Phase ISalt Lake City, UT (801) 584-3600
O6-benzylguanine National Cancer Institute (see also lymphoma, solid tumors, Phase I/III(O6-BG) Bethesda, MD cancer/chemotherapy) N C I T R I A L
Keryx Biopharmaceuticals (800) 4-CANCERNew York, NY
pyrazoloacridine National Cancer Institute glioblastoma multiforme, glioma Phase IBethesda, MD N C I T R I A L
Pfizer (800) 4-CANCERNew York, NY
SDX-102 Salmedix previously treated brain tumors Phase I/II(l-alanosine) San Diego, CA (see also lung, pancreatic, sarcoma) (858) 622-5050
Xcytrin® Pharmacyclics brain metastases from non-small- Phase IIImotexafin Sunnyvale, CA cell lung cancer in combination (408) 774-0330gadolinium with radiotherapy
(see also kidney, leukemia, lung, lymphoma, multiple myeloma, solid tumors)--------------------------------------------------------------------------------------brain metastases in combination Phase IIwith whole brain radiation therapy (408) 774-0330and stereotactic radiosurgery--------------------------------------------------------------------------------------malignant glioma in Phase Icombination with Temodar® (408) 774-0330
Xerecept™ Neurobiological reduction of brain edema Phase IIIcorticotropin- Technologies associated with brain tumors (510) 262-1730releasing factor Richmond, CA (peritumoral brain edema)(CRF)
Xinlay Abbott Laboratories (see also kidney, lung, Phase IIatrasentan Abbott Park, IL ovarian, prostate) (847) 936-1189
B R E A S T C A N C E RProduct Name Sponsor Indication Development Status
17-allylamino- National Cancer Institute (see also kidney, leukemia, Phase IIgeldanamycin Bethesda, MD lymphoma, prostate, skin, N C I T R I A L
Kosan Biosciences solid tumors, other) (800) 4-CANCERHayward, CA
adecatumumab Serono metastatic breast cancer Phase IIRockland, MA (see also prostate) (800) 283-8088
Advexin® Introgen Therapeutics (see also head/neck, lung, Phase II(p53) Austin, TX prostate, stomach, other) (512) 708-9310
arzoxifene Eli Lilly prevention of breast cancer Phase III(next-generation Indianapolis, IN (317) 276-2000SERM)
5M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
B R E A S T C A N C E RProduct Name Sponsor Indication Development Status
atamestane Intarcia Therapeutics combination hormonal therapy for Phase IIIEmeryville, CA treatment of hormone-dependent (510) 652-2600Schering AG breast cancerBerlin, Germany
Avastin™ Genentech metastatic breast cancer Phase IIIbevacizumab South San Francisco, CA (see also colon, kidney, lung, (650) 225-1000
ovarian, pancreatic)
BAY 43-9006 Bayer Pharmaceuticals (see also kidney, leukemia, Phase II(sorafenib) West Haven, CT liver, lung) (203) 937-2000
Onyx Pharmaceuticals (510) 222-9700Richmond, CA
Bonviva® Roche metastatic bone disease in Phase IIIibandronate Nutley, NJ breast cancer (973) 235-5000
breast cancer GlaxoSmithKline treatment of breast cancer Phase Itherapeutic Philadelphia, PA (888) 825-5249(Her 2 Neu) Rsch. Triangle Park, NC (206) 366-3700(recombinant Corixapharmaccine) Seattle, WA
BrevaRex® United Therapeutics (see also multiple myeloma) Phase I completedSilver Spring, MD (301) 608-9292ViRexx (780) 433-4411Edmonton, Alberta
CA4P OXiGENE breast cancer in combination Phase II(combrestatin) Watertown, MA with paclitaxel and carboplatin (617) 673-7800
(see also cervical, colon, head/neck, lung, ovarian, prostate, other)
CMD-193 Wyeth Pharmaceuticals (see also lung) Phase ICollegeville, PA (800) 934-5556
E7070 Eisai (see also colon) Phase IIRidgefield Park, NJ (201) 403-2500
E7389 Eisai (see also lung) Phase IIRidgefield Park, NJ (201) 403-2500
epothilone B National Cancer Institute (see also brain, kidney, liver, Phase IIanalog Bethesda, MD lymphoma, prostate, solid N C I T R I A L
ERA 923 Ligand Pharmaceuticals Phase II(tissue-selective San Diego, CA (858) 550-7500estrogen receptor modulator-SERM)
everolimus Novartis Pharmaceuticals metastatic breast cancer Phase II(RAD001) East Hanover, NJ (973) 781-8300
Evista® Eli Lilly breast cancer prevention, Phase IIIraloxifene Indianapolis, IN reduction of risk of breast cancer (317) 276-2000
Femara™ Novartis Pharmaceuticals adjuvant treatment in breast cancer Phase IIIletrozole East Hanover, NJ (973) 781-8300
6 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
B R E A S T C A N C E RProduct Name Sponsor Indication Development Status
fowlpox and National Cancer Institute (see also lung, solid tumors) Phase I/IIvaccinia CEA Bethesda, MD N C I T R I A L
(6D)/TRICOM Therion Biologics (800) 4-CANCERCambridge, MA
Gemzar® Eli Lilly (see also ovarian) Phase IIIgemcitabine Indianapolis, IN (317) 276-2000
Genasense® Genta (see also colon, kidney, leukemia, Phase IIoblimersen sodium Berkeley Heights, NJ lung, lymphoma, multiple myeloma, (908) 286-9800(G3139) pancreatic, prostate, skin, stomach,
other)
GTI-2040 National Cancer Institute (see also kidney, leukemia, Phase II(antisense) Bethesda, MD lung, prostate, solid tumors) N C I T R I A L
Lorus Therapeutics (800) 4-CANCERToronto, Ontario
GW572016 National Cancer Institute (see also brain, cervical, Phase IIBethesda, MD head/neck, liver, prostate, stomach) N C I T R I A L
GlaxoSmithKline (800) 4-CANCERPhiladelphia, PARsch. Triangle Park, NC
Herceptin® Genentech metastatic breast cancer in application submittedtrastuzumab South San Francisco, CA combination with Taxotere® (650) 225-1000
(see also cervical, sarcoma, solid tumors)--------------------------------------------------------------------------------------adjuvant breast cancer Phase III
(650) 225-1000
HKI-272 Wyeth Pharmaceuticals (see also lung) Phase ICollegeville, PA (800) 934-5556
INGN 225 Introgen Therapeutics (see also lung) Phase I/II(p53 vaccine) Austin, TX (512) 708-9310
Iressa® AstraZeneca advanced refractory breast cancer Phase II(ZD1839) Wilmington, DE (see also colon, head/neck, kidney, (800) 236-9933
lung, solid tumors)
ixabepilone Bristol-Myers Squibb metastatic breast cancer Phase IIIPrinceton, NJ (see also kidney, pancreatic, (212) 546-4000
prostate)
lapatinib GlaxoSmithKline (see also bladder, head/neck, Phase III(ErbB-2 and EGFR Philadelphia, PA kidney, lung, stomach) (888) 825-5249dual kinase Rsch. Triangle Park, NCinhibitor)
LR-103 Bone Care International (see also colon, prostate) Phase IMiddleton, WI (608) 662-7800
MDX-010 Medarex (see also prostate) Phase IIPrinceton, NJ (609) 430-2880
7M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
B R E A S T C A N C E RProduct Name Sponsor Indication Development Status
MoAb 3A1 National Cancer Institute Phase IBethesda, MD N C I T R I A L
(800) 4-CANCER
MST-997 Wyeth Pharmaceuticals (see also lung) Phase ICollegeville, PA (800) 934-5556
Neuvenge® Dendreon (see also colon, ovarian) Phase IAPC8024 Seattle, WA (206) 256-4545
Omnitarg™ Genentech HER2-negative breast cancer Phase IIpertuzumab South San Francisco, CA (see also lung, ovarian) (650) 225-1000
Panvac™-VF Therion Biologics metastatic breast cancer Phase IICambridge, MA (see also colon, lung, pancreatic) (617) 475-7500
Quadramet® Cytogen (see also multiple myeloma, Phase Isamarium Sm Princeton, NJ prostate) (800) 833-3533153 lexidronom
SaponImmune™ Galenica Pharmaceuticals (see also prostate) Phase Iimmune enhancer Birmingham, AL (205) 943-6646
SKI-606 Wyeth Pharmaceuticals (see also colon, leukemia, lung, in clinical trialsCollegeville, PA pancreatic) (800) 934-5556
suramin National Cancer Institute (see also kidney) Phase I/IIBethesda, MD N C I T R I A L
(800) 4-CANCER
Telcyta™ Telik (see also colon, lung, ovarian) Phase II completedTLK286 Palo Alto, CA (866) 485-5286
temsirolimus Wyeth Pharmaceuticals metastatic breast cancer Phase III(CCI-779, Collegeville, PA (see also kidney, lymphoma) (800) 934-5556mTOR inhibitor)
Xeloda® Roche adjuvant treatment of breast cancer Phase IIIcapecitabine Nutley, NJ (see also colon) (973) 235-5000
Xorane IVAX (see also lung, stomach) Phase II completedoral paclitaxel Miami, FL (305) 575-6000
CA4P OXiGENE advanced and recurring cervical Phase I(combrestatin) Watertown, MA cancer in combination with (617) 673-7800
cisplatin(see also breast, colon, head/neck, lung, ovarian, prostate, other)
Cervarix GlaxoSmithKline prevention of cervical cancer Phase IIIrecombinant Philadelphia, PA (888) 825-5249vaccine with Rsch. Triangle Park, NC (301) 398-0000MPL adjuvant MedImmune (206) 366-3700
Gaithersburg, MDCorixaSeattle, WA
EF5 National Cancer Institute (see also head/neck, lung, in clinical trialsBethesda, MD ovarian, cancer/chemotherapy) N C I T R I A L
(800) 4-CANCER
Efaproxyn™ Allos Therapeutics advanced cervical cancer Phase I/IIefaproxiral Westminster, CO (see also brain) (303) 426-6262
Eloxatin® National Cancer Institute (see also liver, lymphoma, Phase IIoxaliplatin Bethesda, MD pancreatic, solid tumors, stomach) N C I T R I A L
ALVAC CEA B7.1 sanofi pasteur metastatic colorectal cancer Phase IIToronto, Ontario (416) 667-2955
Aroplatin™ Antigenics colorectal cancer Phase IINew York, NY (see also solid tumors) (212) 994-8200
Avastin™ Genentech adjuvant colorectal cancer Phase IIIbevacizumab South San Francisco, CA (see also breast, kidney, lung, (650) 225-1000
ovarian, pancreatic)
Avastin™ National Cancer Institute (see also kidney, pancreatic) Phase IIbevacizumab Bethesda, MD N C I T R I A L
Erbitux™ Genentech (800) 4-CANCERcetuximab South San Francisco, CAcombination Bristol-Myers Squibb
Princeton, NJ
Avicine™ AVI BioPharma metastatic colorectal cancer Phase IIItherapeutic Portland, OR (see also pancreatic) (503) 227-0554cancer vaccine SuperGen (925) 327-0200
Dublin, CA
CA4P OXiGENE advanced colorectal cancer in Phase I/II(combrestatin) Watertown, MA combination with MAB A5B7 (617) 673-7800
(see also breast, cervical, head/neck, lung, ovarian, prostate, other)
Celebrex® Pfizer sporadic adenomatous polyposis Phase IIIcelecoxib New York, NY (860) 732-7920
Cotara® Peregrine Pharmaceuticals (see also brain) Phase ITNT-tumor Tustin, CA (714) 508-6000necrosis therapy
CTI-2106 Cell Therapeutics (see also ovarian) Phase IISeattle, WA (206) 282-7100
depsipeptide National Cancer Institute (see also bladder, brain, head/neck, Phase II(FK228) Bethesda, MD leukemia, lung, lymphoma, N C I T R I A L
Gloucester ovarian, skin, solid tumors, (800) 4-CANCERPharmaceuticals stomach, other)Cambridge, MA
10 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
C O L O N C A N C E RProduct Name Sponsor Indication Development Status
E7070 Eisai colorectal cancer Phase IIRidgefield Park, NJ (see also breast) (201) 692-1100
EP-2101 Epimmune colorectal cancer Phase I/IItherapeutic, San Diego, CA (see also lung) (858) 860-2500multi-epitope vaccine
Erbitux™ Bristol-Myers Squibb early stage colorectal cancer Phase IIIcetuximab Princeton, NJ (1st-line, 2nd-line and adjuvant) (212) 546-4000
Imclone Systems (see also head/neck, lung, (908) 218-9588New York, NY pancreatic)
GCS-100® GlycoGenesys colorectal cancer Phase IIBoston, MA (see also pancreatic) (617) 422-0674
Genasense® Genta colorectal cancer Phase IIoblimersen sodium Berkeley Heights, NJ (see also breast, kidney, leukemia, (908) 286-9800(G3139) lung, lymphoma, multiple myeloma,
pancreatic, prostate, skin, stomach, other)
HSG-ETR1 Human Genome Sciences colorectal cancer Phase IIRockville, MD (see also lung, lymphoma) (301) 309-8504
HuC242-DM4 ImmunoGen colorectal cancer Phase ICambridge, MA (see also pancreatic, stomach) (617) 995-2500
HumASPECT® Intracel Resources monitoring of colon cancer application submitted88BV59 Frederick, MD (301) 668-8400
Iressa® AstraZeneca advanced colon cancer Phase II(ZD1839) Wilmington, DE (see also breast, head/neck, kidney, (800) 236-9933
lung, solid tumors)
LE-SN38 NeoPharm colorectal cancer Phase II(liposome Lake Forest, IL (847) 295-8678entrapped SN-38)
LR-103 Bone Care International (see also breast, prostate) Phase IMiddleton, WI (608) 662-7800
MoAb: I-131 National Cancer Institute Phase IHuCC49 Delta Bethesda, MD N C I T R I A L
CH2 (800) 4-CANCER
Neuvenge® Dendreon colorectal cancer Phase IAPC8024 Seattle, WA (see also breast, ovarian) (206) 256-4545
NX473 AnorMED colorectal cancer Phase IILangley, British Columbia (see also lung, solid tumors) (888) 879-7007NeoRxSeattle, WA
11M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
C O L O N C A N C E RProduct Name Sponsor Indication Development Status
OncoVAX® Intracel Resources stage II colon cancer Phase III completedautologous Frederick, MD (301) 668-8400vaccine --------------------------------------------------------------------------------------
stage III colon cancer Phase IIIin combination with chemotherapy (301) 668-8400
p53 and ras National Cancer Institute (see also lung, ovarian) Phase I/IIpeptide vaccine Bethesda, MD N C I T R I A L
Amgen (800) 4-CANCERThousand Oaks, CA
panitumumab Abgenix metastatic colorectal cancer Phase III(ABX-EGF) Fremont, CA (see also kidney, lung) (805) 447-1000
AmgenThousand Oaks, CA
Panvac™-VF Therion Biologics metastatic colorectal cancer Phase ICambridge, MA (see also breast, lung, pancreatic) (617) 475-7500
SKI-606 Wyeth Pharmaceuticals colorectal cancer in clinical trialsCollegeville, PA (see also breast, leukemia, lung, (800) 934-5556
pancreatic)
sodium National Cancer Institute (see also leukemia, solid tumors) Phase I/IIphenylbutyrate Bethesda, MD N C I T R I A L
Vectramed (800) 4-CANCERPlainsboro, NJ
Telcyta™ Telik colorectal cancer Phase II completedTLK286 Palo Alto, CA (see also breast, lung, ovarian) (866) 485-5286
vatalanib Novartis Pharmaceuticals colorectal cancer Phase III(PTK 787) East Hanover, NJ (973) 781-8300
Schering AGBerlin, Germany
Xeloda® Roche adjuvant and metastatic Phase IIIcapecitabine Nutley, NJ combination treatment of (973) 235-5000
colon cancer(see also breast)
H E A D / N E C K C A N C E RProduct Name Sponsor Indication Development Status
Advexin® National Cancer Institute head and neck, including lip and Phase I/II(p53) Bethesda, MD oral cavity N C I T R I A L
Introgen Therapeutics (800) 4-CANCERAustin, TX----------------------------------------------------------------------------------------------------------------------------Introgen Therapeutics head and neck cancer Phase IIIAustin, TX (see also breast, lung, prostate, (512) 708-9310
stomach, other)
12 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
H E A D / N E C K C A N C E RProduct Name Sponsor Indication Development Status
CA4P OXiGENE head/neck cancer in combination Phase I/II(combrestatin) Watertown, MA with radiotherapy (617) 673-7800
(see also breast, cervical, colon, lung, ovarian, prostate, other)
cytochlor and National Cancer Institute oral cavity cancer Phase Itetrahydrouridine Bethesda, MD (see also stomach) N C I T R I A L
(FK228) Halogenetics (800) 4-CANCERMiami, FL
depsipeptide National Cancer Institute (see also bladder, brain, colon, Phase II(FK228) Bethesda, MD leukemia, lung, lymphoma, N C I T R I A L
Gloucester ovarian, skin, solid tumors, (800) 4-CANCERPharmaceuticals stomach, other)Cambridge, MA
EF5 National Cancer Institute (see also cervical, lung, Phase IBethesda, MD ovarian, cancer/chemotherapy) N C I T R I A L
(800) 4-CANCER
Erbitux™ Bristol-Myers Squibb (see also colon, lung, pancreatic) Phase IIIcetuximab Princeton, NJ (212) 546-4000
Imclone Systems (908) 218-9588New York, NY
GW572016 National Cancer Institute salivary gland cancer, Phase IIBethesda, MD squamous cell carcinoma N C I T R I A L
GlaxoSmithKline (see also brain, breast, cervical, (800) 4-CANCERPhiladelphia, PA liver, prostate, stomach)Rsch. Triangle Park, NC
HumaRAD Intracel Resources (see also ovarian) Phase I16.88/88BV59 Frederick, MD (301) 668-8400
Iressa® AstraZeneca (see also breast, colon, kidney, Phase II(ZD1839) Wilmington, DE lung, solid tumors) (800) 236-9933
lapatinib GlaxoSmithKline (see also bladder, breast, Phase III(ErbB-2 and EGFR Philadelphia, PA kidney, lung, stomach) (888) 825-5249dual kinase Rsch. Triangle Park, NCinhibitor)
MedPulser® Inovio Biomedical squamous cell carcinoma of the Phase IIITherapy System San Diego, CA anterior oral cavity or pharynx (858) 597-6006
and larynx that has failed primary curative therapy(see also pancreatic)
Multikine® CEL-SCI advanced primary squamous cell Phase II completedleukocyte Vienna, VA carcinoma of the oral cavity (703) 506-9460interleukin, (see also prostate)injection --------------------------------------------------------------------------------------
locally recurrent/locally metastatic Phase I/II completedhead/neck cancer (703) 506-9460
Proxinium™ Viventia Biotech (see also bladder) Phase IToronto, Ontario (416) 291-1277
13M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
H E A D / N E C K C A N C E RProduct Name Sponsor Indication Development Status
Taxotere® Sanofi-aventis (see also stomach) Phase IIIdocetaxel Bridgewater, NJ (800) 633-1610
K I D N E Y C A N C E RProduct Name Sponsor Indication Development Status
17-allylamino- National Cancer Institute (see also breast, leukemia, Phase IIgeldanamycin Bethesda, MD lymphoma, prostate, skin, N C I T R I A L
Kosan Biosciences solid tumors, other) (800) 4-CANCERHayward, CA
485232 GlaxoSmithKline immunologically sensitive renal Phase II(recombinant Philadelphia, PA cell cancer (888) 825-5249human IL-18 Rsch. Triangle Park, NC (see also skin)immunomodulator)
AG-013736 Pfizer (see also lung, pancreatic, skin, Phase IINew York, NY other) (860) 732-7920
Avastin™ Genentech renal cell carcinoma Phase IIIbevacizumab South San Francisco, CA (see also breast, colon, lung, (650) 225-1000
ovarian, pancreatic)
Avastin™ National Cancer Institute (see also colon, pancreatic) Phase I/IIbevacizumab Bethesda, MD N C I T R I A L
Erbitux™ Genentech (800) 4-CANCERcetuximab South San Francisco, CAcombination Bristol-Myers Squibb
Princeton, NJ
BAY 43-9006 Bayer Pharmaceuticals advanced kidney cancer Phase III(sorafenib) West Haven, CT (see also breast, leukemia, (203) 937-2000
Onyx Pharmaceuticals liver, lung) (510) 222-9700Richmond, CA
expanded National Cancer Institute renal cell carcinoma Phase IIactivated Bethesda, MD N C I T R I A L
T cells plus IL-2 (800) 4-CANCER
FGF-5:172-176/ National Cancer Institute renal cell carcinoma Phase II217-220 Bethesda, MD N C I T R I A L
peptide vaccine (800) 4-CANCER
14 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
K I D N E Y C A N C E RProduct Name Sponsor Indication Development Status
Genasense® Genta renal cell cancer Phase IIoblimersen sodium Berkeley Heights, NJ (see also breast, colon, leukemia, (908) 286-9800(G3139) lung, lymphoma, multiple myeloma,
pancreatic, prostate, skin, stomach, other)
GTI-2040 Lorus Therapeutics (see also breast, leukemia, lung, Phase II(antisense) Toronto, Ontario prostate, solid tumors) (416) 798-1200
IMOxine™ Hybridon renal cell carcinoma Phase IICambridge, MA (617) 679-5500
interleukin-12 National Cancer Institute (see also lymphoma, ovarian, Phase Iarsenic trioxide Bethesda, MD solid tumors) N C I T R I A L
Wyeth Pharmaceuticals (800) 4-CANCERCollegeville, PA
Iressa® AstraZeneca (see also breast, colon, head/neck, Phase II(ZD1839) Wilmington, DE lung, solid tumors) (800) 236-9933
ixabepilone Bristol-Myers Squibb renal cancer Phase IIPrinceton, NJ (see also breast, pancreatic, (212) 546-4000
prostate)
lapatinib GlaxoSmithKline (see also bladder, breast, Phase III(ErbB-2 and EGFR Philadelphia, PA head/neck, lung, stomach) (888) 825-5249dual kinase Rsch. Triangle Park, NCinhibitor)
Oncophage® Antigenics nonmetastatic kidney cancer Phase IIIHSPPC-96 New York, NY (see also lung, skin) (212) 994-8200
--------------------------------------------------------------------------------------metastatic kidney cancer Phase II
(212) 994-8200
panitumumab Abgenix renal cell cancer Phase II(ABX-EGF) Fremont, CA (see also colon, lung) (805) 447-1000
AmgenThousand Oaks, CA
SU11248 Pfizer metastatic renal cell carcinoma Phase IIINew York, NY (see also solid tumors) (860) 732-7920
suramin National Cancer Institute (see also breast) Phase I/IIBethesda, MD N C I T R I A L
(800) 4-CANCER
temsirolimus Wyeth Pharmaceuticals renal cell carcinoma Phase III(CCI-779, Collegeville, PA (see also breast, lymphoma) (800) 934-5556mTOR inhibitor)
Thalomid® Celgene renal cell cancer Phase IIIthalidomide Summit, NJ (see also multiple myeloma, (908) 673-9000
prostate)
tumor-derived Cancer Therapeutics (see also skin) Phase IIactivated cells Thomasville, GA (800) 297-2976(TDAC)
15M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
K I D N E Y C A N C E RProduct Name Sponsor Indication Development Status
Xcytrin® Pharmacyclics renal cell carcinoma Phase IImotexafin Sunnyvale, CA (see also brain, leukemia, lung, (408) 774-0330gadolinium lymphoma, multiple myeloma,
solid tumors)
Xinlay Abbott Laboratories (see also brain, lung, ovarian, Phase IIatrasentan Abbott Park, IL prostate) (847) 936-1189
L E U K E M I AProduct Name Sponsor Indication Development Status
17-allylamino- National Cancer Institute (see also breast, kidney, Phase Igeldanamycin Bethesda, MD lymphoma, prostate, skin, N C I T R I A L
Kosan Biosciences solid tumors, other) (800) 4-CANCERHayward, CA
506U78 National Cancer Institute (see also lymphoma) Phase IIBethesda, MD N C I T R I A L
GlaxoSmithKline (800) 4-CANCERPhiladelphia, PARsch. Triangle Park, NC
AEG 35156 XIAP Aegera Therapeutics acute leukemia Phase Iinhibitor Nun’s Island, Quebec (see also solid tumors) (514) 288-5532
AG-858 Antigenics chronic myelogenous leukemia Phase II(HSPPC-70) New York, NY (CML) (212) 994-8200
AP23573 ARIAD Pharmaceuticals hematological malignancies Phase II(mTOR inhibitor) Cambridge, MA (see also brain, cervical, (617) 494-0400
CEP-701 Cephalon AML Phase IIlestaurtinib West Chester, PA (610) 344-0200
Ceplene™ Maxim Pharmaceuticals AML Phase IIIhistamine San Diego, CA (858) 453-4040dihydrochloride
CHIR-12.12 Chiron CLL Phase IEmeryville, CA (510) 655-8730XOMABerkeley, CA
CHIR-258 Chiron AML Phase IEmeryville, CA (see also solid tumors) (510) 655-8730
Cloretazine™ Vion Pharmaceuticals relapsed AML Phase IIIVNP40101M New Haven, CT (see also brain) (203) 498-4210(Orphan Drug) --------------------------------------------------------------------------------------
GVAX® Leukemia Cell Genesys Phase IIcancer vaccine South San Francisco, CA (650) 226-3000
LMB-2 National Cancer Institute (see also lymphoma) Phase I/IIimmunotoxin Bethesda, MD N C I T R I A L
(800) 4-CANCER
Marqibo™ Inex Pharmaceuticals relapsed ALL Phase IIvincristine sulfate Burnaby, British Columbia (see also lymphoma) (604) 419-3200liposomes injection
midostaurine Novartis Pharmaceuticals AML Phase I/II(PKC 412) East Hanover, NJ (see also solid tumors) (973) 781-8300
MLN 518 Millennium Pharmaceuticals AML Phase I/IICambridge, MA (800) 589-9005
MS-275 National Cancer Institute (see also skin, solid tumors) Phase Ihistone Bethesda, MD N C I T R I A L
deacetylase Schering AG (800) 4-CANCERinhibitor Berlin, Germany
nelarabine GlaxoSmithKline acute lymphoblastic leukemia Phase III(guanine Philadelphia, PA (see also lymphoma) (888) 825-5249arabinoside Rsch. Triangle Park, NCprodrug)
ONTAK® Ligand Pharmaceuticals CLL Phase IIdenileukin diftitex San Diego, CA (see also lymphoma, (858) 550-7500
cancer/chemotherapy)
Pivanex® Titan Pharmaceuticals CLL Phase IISouth San Francisco, CA (see also lung) (650) 244-4990
proteinase 3 National Cancer Institute Phase I/IIpeptide vaccine Bethesda, MD N C I T R I A L
(PR-1) (800) 4-CANCER
rebeccamycin National Cancer Institute (see also liver, solid tumors) Phase Ianalog Bethesda, MD N C I T R I A L
Exelixis (800) 4-CANCERSouth San Francisco, CA
18 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
L E U K E M I AProduct Name Sponsor Indication Development Status
Revlimid™ Celgene MDS Phase IIlenalidomide Summit, NJ (see also multiple myeloma, (908) 673-9000
skin, solid tumors)
Rituxan® Biogen Idec relapsed CLL Phase IIIrituximab Cambridge, MA (see also lymphoma) (650) 225-1000
GenentechSouth San Francisco, CA
Sarasar Schering-Plough (see also solid tumors) Phase IIlonafarnib Kenilworth, NJ (908) 298-4000
SDX-101 Salmedix CLL Phase II(R-etodolac) San Diego, CA (858) 622-5050
SKI-606 Wyeth Pharmaceuticals CML in clinical trialsCollegeville, PA (see also breast, colon, lung, (800) 934-5556
pancreatic)
sodium National Cancer Institute (see also colon, solid tumors) Phase Iphenylbutyrate Bethesda, MD N C I T R I A L
Vectramed (800) 4-CANCERPlainsboro, NJ
SRC/ABL kinase Bristol-Myers Squibb CML Phase IIinhibitor Princeton, NJ (see also solid tumors) (212) 546-4000
Telintra™ Telik MDS Phase IITLK199 Palo Alto, CA (866) 485-5286
Trisenox® Cell Therapeutics MDS, CML, acute promyelocytic Phase IIarsenic trioxide Seattle, WA leukemia (APL) (206) 282-7100injection (see also multiple myeloma,
neuroblastoma, solid tumors)
Troxatyl™ SGX relapsed AML Phase ISan Diego, CA (see also solid tumors) (858) 558-4850
Xcytrin® Pharmacyclics CLL Phase IImotexafrin Sunnyvale, CA (see also brain, kidney, lung, (408) 774-0330gadolinium lymphoma, multiple myeloma,
solid tumors)
XK469 National Cancer Institute (see also lymphoma) Phase IBethesda, MD N C I T R I A L
Bristol-Myers Squibb (800) 4-CANCERPrinceton, NJ
19M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
L E U K E M I AProduct Name Sponsor Indication Development Status
Zarnestra™ Johnson & Johnson AML application submittedtipifarnib Pharmaceutical Research (see also breast) (800) 817-5286(R115777) & Development -------------------------------------------------------------------------------------
Raritan, NJ MDS Phase II(800) 817-5286
ZYC300 MGI Pharma metastatic hematological cancer Phase I/II completedMinneapolis, MN (see also solid tumors) (952) 346-4700
L I V E R C A N C E RProduct Name Sponsor Indication Development Status
BAY 43-9006 Bayer Pharmaceuticals advanced liver cancer Phase III(sorafenib) West Haven, CT (see also breast, kidney, leukemia, (203) 937-2000
Onyx Pharmaceuticals lung) (510) 222-9700Richmond, CA
DENSPM Genzyme Phase I/IICambridge, MA (617) 252-7500
Eloxatin® National Cancer Institute (see also cervical, lymphoma, Phase I/IIoxaliplatin Bethesda, MD pancreatic, solid tumors, N C I T R I A L
Iressa® AstraZeneca NSCLC Phase II/III(ZD1839) Wilmington, DE (see also breast, colon, head/neck, (800) 236-9933
kidney, solid tumors)
lapatinib GlaxoSmithKline (see also bladder, breast, Phase III(ErbB-2 and EGFR Philadelphia, PA head/neck, kidney, stomach) (888) 825-5249dual kinase Rsch. Triangle Park, NCinhibitor)
MAC-321 Wyeth Pharmaceuticals NSCLC Phase IICollegeville, PA (800) 934-5556
mage 3 GlaxoSmithKline treatment of lung cancer Phase II(249553; Philadelphia, PA (see also skin) (888) 825-5249recombinant Rsch. Triangle Park, NCpharmaccine)
SAI-EGF CancerVax NSCLC Phase I/IICarlsbad, CA (760) 494-4200
SDX-102 Salmedix mesothelioma, NSCLC Phase II(l-alanosine) San Diego, CA (see also brain, pancreatic, sarcoma) (858) 622-5050
SGN-15 Seattle Genetics NSCLC Phase II(cBR96-doxorubicin Bothell, WA (425) 527-4000immunoconjugate)
SKI-606 Wyeth Pharmaceuticals NSCLC in clinical trialsCollegeville, PA (see also breast, colon, leukemia, (800) 934-5556
pancreatic)
24 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
L U N G C A N C E RProduct Name Sponsor Indication Development Status
Tarceva™ Genentech adjuvant NSCLC Phase IIIerlotinib South San Francisco, CA (see also pancreatic) (650) 225-1000
OSI Pharmaceuticals (800) 572-1932Melville, NY (973) 235-5000RocheNutley, NJ
Targretin® Capsules Ligand Pharmaceuticals Phase IIIbexarotene San Diego, CA (858) 550-7500(LGD 1069)
tasidotin Genzyme NSCLC Phase IICambridge, MA (see also prostate, skin) (617) 252-7500
Telcyta™ Telik advanced NSCLC Phase IIITLK286 Palo Alto, CA (see also breast, colon, ovarian) (866) 485-5286
--------------------------------------------------------------------------------------NSCLC Phase II completed
(866) 485-5286--------------------------------------------------------------------------------------NSCLC in combination with Phase IIcarboplatin and paclitaxel (866) 485-5286--------------------------------------------------------------------------------------NSCLC in combination with Phase IIcisplatin (866) 485-5286
UCN-01 National Cancer Institute (see also lymphoma, pancreatic, Phase IIBethesda, MD skin, solid tumors) N C I T R I A L
Kyowa Pharmaceutical (800) 4-CANCERPrinceton, NJ
Velcade® Millennium Pharmaceuticals NSCLC Phase IIbortezomib Cambridge, MA (see also lymphoma, solid tumors) (800) 589-9005
vinflunine Bristol-Myers Squibb NSCLC Phase IIIPrinceton, NJ (see also bladder) (212) 546-4000
Xcytrin® Pharmacyclics NSCLC Phase IImotexafin Sunnyvale, CA (see also brain, kidney, leukemia, (408) 774-0300gadolinium lymphoma, multiple myeloma,
solid tumors)--------------------------------------------------------------------------------------NSCLC in combination with Phase IITaxotere® (408) 774-0300--------------------------------------------------------------------------------------NSCLC in combination with Phase Icisplatin and Taxotere® (408) 774-0300
Xinlay Abbott Laboratories (see also brain, kidney, ovarian, Phase IIatrasentan Abbott Park, IL prostate) (847) 936-1189
Xorane IVAX (see also breast, stomach) Phase II completedoral paclitaxel Miami, FL (305) 575-6000
Xyotax™ Cell Therapeutics NSCLC Phase IIIpolyglutamate Seattle, WA (see also ovarian, solid tumors) (206) 282-7100paclitaxel
25M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
L Y M P H O M AProduct Name Sponsor Indication Development Status
17-allylamino- National Cancer Institute (see also breast, kidney, Phase Igeldanamycin Bethesda, MD leukemia, prostate, skin, N C I T R I A L
Kosan Biosciences solid tumors, other) (800) 4-CANCERHayward, CA
17-DMAG National Cancer Institute (see also solid tumors) Phase IBethesda, MD N C I T R I A L
Kosan Biosciences (800) 4-CANCERHayward, CA
506U78 National Cancer Institute (see also leukemia) Phase IIBethesda, MD N C I T R I A L
GlaxoSmithKline (800) 4-CANCERPhiladelphia, PARsch. Triangle Park, NC
AMD-3100 AnorMED non-Hodgkin lymphoma (NHL) Phase IIILangley, British Columbia (see also multiple myeloma) (604) 530-1057
AP23573 ARIAD Pharmaceuticals (see also brain, cervical, leukemia, Phase I(mTOR inhibitor) Cambridge, MA multiple myeloma, prostate, (617) 494-0400
sarcoma, solid tumors)
apolizumab National Cancer Institute (see also leukemia) Phase I(Hu1D10) and Bethesda, MD N C I T R I A L
Rituxan® Protein Design Labs (800) 4-CANCERFremont, CA
BIOVAXID™ Accentia indolent, follicular NHL Phase IIIBioPharmaceuticals (877) 654-6052Morrisville, NC
bryostatin 1 National Cancer Institute NHL Phase IIBethesda, MD (see also leukemia) N C I T R I A L
(800) 4-CANCER
Campath® Berlex Laboratories NHL Phase I/IIalemtuzumab Montville, NJ (see also leukemia) (617) 252-7500
GenzymeCambridge, MA
carboxyamido- National Cancer Institute (see also other) Phase Itriazole Bethesda, MD N C I T R I A L
(CAI) (800) 4-CANCER
CB3304 Cougar Biotechnology NHL Phase ILos Angeles, CA (310) 443-4209
CMC-544 Wyeth Pharmaceuticals NHL Phase ICollegeville, PA (800) 934-5556
depsipeptide National Cancer Institute (see also bladder, brain, colon, Phase I/II(FK228) Bethesda, MD head/neck, leukemia, lung, N C I T R I A L
Gloucester ovarian, skin, solid tumors, (800) 4-CANCERPharmaceuticals stomach, other)Cambridge, MA
26 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
L Y M P H O M AProduct Name Sponsor Indication Development Status
Eloxatin® National Cancer Institute (see also cervical, liver, Phase Ioxaliplatin Bethesda, MD pancreatic, solid tumors, N C I T R I A L
Ganite® Genta NHL Phase IIgallium nitrate Berkeley Heights, NJ (908) 286-9800injection
Genasense® Genta NHL Phase IIoblimersen sodium Berkeley Heights, NJ (see also breast, colon, kidney, (908) 286-9800(G3139) leukemia, lung, multiple myeloma,
pancreatic, prostate, skin, stomach, other)
hCD20 Immunomedics NHL Phase I(IMMU-106) Morris Plains, NJ (973) 605-8200
HSG-ETR1 Human Genome Sciences NHL Phase IIRockville, MD (see also colon, lung) (301) 309-8504
IL-12 plus IL-2 National Cancer Institute (see also neuroblastoma) Phase IBethesda, MD N C I T R I A L
Chiron (800) 4-CANCEREmeryville, CAWyeth PharmaceuticalsCollegeville, PA
interleukin-12 National Cancer Institute (see also kidney, ovarian, Phase II(IL-12) Bethesda, MD solid tumors) N C I T R I A L
Wyeth Pharmaceuticals (800) 4-CANCERCollegeville, PA
LMB-2 National Cancer Institute (see also leukemia) Phase I/IIimmunotoxin Bethesda, MD N C I T R I A L
(800) 4-CANCER
27M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
L Y M P H O M AProduct Name Sponsor Indication Development Status
Marqibo™ Inex Pharmaceuticals relapsed, aggressive NHL Phase IIIvincristine sulfate Burnaby, British Columbia (see also leukemia) (604) 419-3200liposomes --------------------------------------------------------------------------------------injection relapsed Hodgkin disease Phase II
(604) 419-3200--------------------------------------------------------------------------------------1st-line NHL (combination therapy) Phase II
(604) 419-3200--------------------------------------------------------------------------------------relapsed NHL in combination with Phase IIRituxan® (604) 419-3200--------------------------------------------------------------------------------------relapsed NHL in combination with Phase IIetoposide (604) 419-3200
MoAb HeFi-1 National Cancer Institute Phase IBethesda, MD N C I T R I A L
(800) 4-CANCER
nelarabine GlaxoSmithKline (see also leukemia) Phase III(guanine Philadelphia, PA (888) 825-5249arabinoside Rsch. Triangle Park, NCprodrug)
O6-benzylguanine National Cancer Institute (see also brain, solid tumors, Phase II(O6-BG) Bethesda, MD cancer/chemotherapy) N C I T R I A L
Keryx Biopharmaceuticals (800) 4-CANCERNew York, NY
Oncolym® Peregrine Pharmaceuticals Phase ITustin, CA (714) 508-6000
ONTAK™ Ligand Pharmaceuticals B-cell NHL Phase IIdenileukin diftitox San Diego, CA (see also leukemia, (858) 550-7500
cancer/chemotherapy)
pixantrone Cell Therapeutics aggressive NHL Phase III(BBR 2778) Seattle, WA (206) 282-7100
PPI-2458 Praecis Pharmaceuticals NHL Phase IWaltham, MA (781) 795-4100
pralatrexate Allos Therapeutics NHL Phase I/IIWestminster, CO (see also lung) (303) 426-6262
Proleukin® Chiron refractory low-grade NHL in Phase IIaldesleukin Emeryville, CA combination with Rituxan® (510) 655-8730(IL-2) (see also skin)
--------------------------------------------------------------------------------------refractory high-grade NHL in Phase IIcombination with Rituxan® and (510) 655-8730chemotherapy
28 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
L Y M P H O M AProduct Name Sponsor Indication Development Status
ProMune® Coley Pharmaceutical cutaneous T-cell lymphoma (CTCL) Phase IIWellesley, MA (see also lung, skin) (781) 431-9000
Rituxan® Genentech treatment of frontline indolent NHL, Phase III completedrituximab South San Francisco, CA frontline aggressive NHL, indolent (650) 225-1000
Biogen Idec maintenance NHLCambridge, MA (see also leukemia)
temsirolimus Wyeth Pharmaceuticals mantle cell lymphoma Phase II(CCI-779, mTOR Collegeville, PA (see also breast, kidney) (800) 934-5556inhibitor)
Treanda™ Salmedix NHL Phase IIbendamustine HCl San Diego, CA (858) 622-5050
UCN-01 National Cancer Institute (see also lung, pancreatic, skin, Phase I/II(KW-2401) Bethesda, MD solid tumors) N C I T R I A L
Kyowa Pharmaceutical (800) 4-CANCERPrinceton, NJ
Velcade® Millennium Pharmaceuticals mantle cell lymphoma, NHL Phase IIbortezomib Cambridge, MA (see also lung, solid tumors) (800) 589-9005
Xcytrin® Pharmacyclics low-grade NHL Phase IImotexafin Sunnyvale, CA (see also brain, kidney, leukemia, (408) 774-0330gadolinium lung, multiple myeloma,
solid tumors)--------------------------------------------------------------------------------------NHL in combination with Zevalin® Phase I/II
(408) 774-0330
XK469 National Cancer Institute (see also leukemia) Phase IBethesda, MD N C I T R I A L
Bristol-Myers Squibb (800) 4-CANCERPrinceton, NJ
Y-90 epratuzumab Immunomedics indolent and aggressive NHL Phase I(IMMU-102) Morris Plains, NJ (973) 605-8200
Zevalin® National Cancer Institute Phase I/IIBethesda, MD N C I T R I A L
Biogen Idec (800) 4-CANCERCambridge, CA
29M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
M U L T I P L E M Y E L O M AProduct Name Sponsor Indication Development Status
Actimid™ Celgene (see also prostate) Phase ISummit, NJ (908) 673-9000
AMD-3100 AnorMED (see also lymphoma) Phase IIILangley, British Columbia (604) 530-1057
AP23573 ARIAD Pharmaceuticals (see also brain, cervical, leukemia, Phase I(mTOR inhibitor) Cambridge, MA lymphoma, prostate, sarcoma, (617) 494-0400
solid tumors)
BrevaRex® United Therapeutics (see also breast) Phase I completedSilver Spring, MD (301) 608-9292ViRexx (780) 433-4411Edmonton, Alberta
GCS-100LE™ GlycoGenesys (see also solid tumors) Phase I/IIBoston, MA (617) 422-0674
Genasense® Genta (see also breast, colon, kidney, Phase IIIoblimersen sodium Berkeley Heights, NJ leukemia, lung, lymphoma, (908) 286-9800(G3139) pancreatic, prostate, skin,
stomach, other)
GVAX® Myeloma Cell Genesys Phase I/IIcancer vaccine South San Francisco, CA (650) 266-3000
HuN901-DM1 ImmunoGen (see also lung) Phase ICambridge, MA (617) 995-2500
MRA Chugai Pharma USA Phase I(tocilizumab) San Diego, CA (858) 535-5900
myeloma-derived National Cancer Institute Phase I/IIidiotypic antigen Bethesda, MD N C I T R I A L
Quadramet® Cytogen (see also breast, prostate) Phase Isamarium Sm Princeton, NJ (800) 833-3533153 lexidronom
Revlimid™ Celgene (see also leukemia, skin, Phase IIIlenalidomide Summit, NJ solid tumors) (908) 673-9000
SGN-40 Seattle Genetics (see also lymphoma) Phase I(Orphan Drug) Bothell, WA (425) 527-4000
STR™ NeoRx Phase IIIskeletal targeted Seattle, WA (206) 281-7001radiotherapy
TACI-Ig Serono (see also other) Phase IIRockland, MA (800) 283-8088
Thalomid® Celgene (see also kidney, prostate) application submittedthalidomide Summit, NJ (908) 673-9000
30 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
M U L T I P L E M Y E L O M AProduct Name Sponsor Indication Development Status
Trisenox® Cell Therapeutics multiple myeloma Phase IIarsenic trioxide Seattle, WA (see also leukemia, neuroblastoma, (206) 282-7100injection solid tumors)
Xcytrin® Pharmacyclics (see also brain, kidney, leukemia, Phase IImotexafin Sunnyvale, CA lung, lymphoma, solid tumors) (408) 774-0330gadolinium
N E U R O B L A S T O M AProduct Name Sponsor Indication Development Status
chimeric National Cancer Institute Phase IIIMoAb 14.18 Bethesda, MD N C I T R I A L
(800) 4-CANCER
IL-12 plus IL-2 National Cancer Institute (see also lymphoma) Phase IBethesda, MD N C I T R I A L
Chiron (800) 4-CANCEREmeryville, CAWyeth PharmaceuticalsCollegeville, PA
Trisenox® Cell Therapeutics (see also leukemia, multiple Phase IIarsenic trioxide Seattle, WA myeloma, solid tumors) (206) 282-7100injection
O V A R I A N C A N C E RProduct Name Sponsor Indication Development Status
Avastin™ Genentech 1st-line treatment Phase IIIbevacizumab South San Francisco, CA (see also breast, colon, kidney, (650) 225-1000
lung, pancreatic)
CA4P OXiGENE ovarian cancer in combination Phase II(combrestatin) Watertown, MA with paclitaxel and carboplatin (617) 673-7800
(see also breast, cervical, colon, head/neck, lung, prostate, other)--------------------------------------------------------------------------------------ovarian cancer in combination Phase I/IIwith paclitaxel or carboplatin (617) 673-7800
CTI-2106 Cell Therapeutics (see also colon) Phase IISeattle, WA (206) 282-7100
depsipeptide National Cancer Institute (see also bladder, brain, colon, Phase II(FK228) Bethesda, MD head/neck, leukemia, lung, N C I T R I A L
Gloucester lymphoma, skin, solid tumors, (800) 4-CANCERPharmaceuticals stomach, other)Cambridge, MA
EF5 National Cancer Institute (see also cervical, head/neck, Phase IIBethesda, MD lung, cancer/chemotherapy) N C I T R I A L
(800) 4-CANCER
31M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
O V A R I A N C A N C E RProduct Name Sponsor Indication Development Status
flavopiridol National Cancer Institute (see also leukemia, liver, Phase IIBethesda, MD lymphoma, pancreatic, sarcoma, N C I T R I A L
p53 and ras National Cancer Institute (see also colon, lung) Phase I/IIpeptide vaccine Bethesda, MD N C I T R I A L
Amgen (800) 4-CANCERThousand Oaks, CA
phenoxodiol Marshall Edwards Phase I/IINew York, NY (203) 327-1188NovogenStamford, CT
Telcyta™ Telik advanced ovarian cancer Phase IIITLK286 Palo Alto, CA (see also breast, colon, lung) (866) 485-5286
--------------------------------------------------------------------------------------advanced ovarian cancer in Phase IIIcombination with carboplatin (866) 485-5286--------------------------------------------------------------------------------------ovarian cancer Phase II completed
(866) 485-5286
Xinlay Abbott Laboratories (see also brain, kidney, lung, Phase IIatrasentan Abbott Park, IL prostate) (847) 936-1189
32 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
O V A R I A N C A N C E RProduct Name Sponsor Indication Development Status
Xyotax™ Cell Therapeutics (see also lung, solid tumors) Phase IIIpolyglutamate Seattle, WA (206) 282-7100paclitaxel
Yondelis™ Johnson & Johnson (see also breast, sarcoma) Phase III(ET-743) Pharmaceutical Research (800) 817-5286(Orphan Drug) & Development
Raritan, NJPharmaMar USACambridge, MA
P A N C R E A T I C C A N C E RProduct Name Sponsor Indication Development Status
AG-013736 Pfizer (see also kidney, lung, skin, Phase IINew York, NY other) (860) 732-7920
Avastin™ Genentech locally advanced pancreatic cancer Phase IIIbevacizumab South San Francisco, CA (see also breast, colon, kidney, (650) 225-1000
lung, ovarian)
Avastin™ National Cancer Institute (see also colon, kidney) Phase IIbevacizumab Bethesda, MD N C I T R I A L
Erbitux™ Genentech (800) 4-CANCERcetuximab South San Francisco, CAcombination Bristol-Myers Squibb
Princeton, NJ
Avicine™ AVI BioPharma (see also colon) Phase II completedtherapeutic Portland, OR (503) 227-0554cancer vaccine SuperGen (925) 327-0200
Dublin, CA
Eloxatin® National Cancer Institute (see also cervical, liver, Phase I/IIIoxaliplatin Bethesda, MD lymphoma, solid tumors, stomach) N C I T R I A L
Sanofi-aventis (800) 4-CANCERBridgewater, NJ
Erbitux™ Bristol-Myers Squibb (see also colon, head/neck, Phase IIIcetuximab Princeton, NJ lung) (212) 546-4000
Imclone Systems (908) 218-9588New York, NY
flavopiridol National Cancer Institute (see also leukemia, liver, Phase IBethesda, MD lymphoma, ovarian, sarcoma, N C I T R I A L
34 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
P R O S T A T E C A N C E RProduct Name Sponsor Indication Development Status
17-allylamino- National Cancer Institute (see also breast, kidney, Phase IIgeldanamycin Bethesda, MD leukemia, lymphoma, skin, N C I T R I A L
Kosan Biosciences solid tumors, other) (800) 4-CANCERHayward, CA
Actimid™ Celgene (see also multiple myeloma) Phase IISummit, NJ (908) 673-9000
adecatumumab Serono (see also breast) Phase IIRockland, MA (800) 283-8088
Advexin® Introgen Therapeutics (see also breast, head/neck, Phase I completed(p53) Austin, TX lung, stomach, other) (512) 708-9310
AP23573 ARIAD Pharmaceuticals hormone refractory prostate cancer Phase II(mTOR inhibitor) Cambridge, MA (see also brain, cervical, leukemia, (617) 494-0400
MLN2704 Millennium Pharmaceuticals Phase I/IICambridge, MA (800) 589-9005
modrenal Bioenvision Phase IINew York, NY (212) 750-6700
Multikine™ CEL-SCI newly diagnosed advanced primary Phase I completedleukocyte Vienna, VA prostate cancer (703) 506-9460interleukin, (see also head/neck)injection
36 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
P R O S T A T E C A N C E RProduct Name Sponsor Indication Development Status
485232 GlaxoSmithKline immunologically-sensitive Phase II(recombinant Philadelphia, PA melanoma (888) 825-5249human IL-18 Rsch. Triangle Park, NC (see also kidney)immunomodulator)
A-007 DEKK-TEC breast cancer, lymphomas, and Phase I completedNew Orleans, LA melanoma spread to skin and other
cutaneous sites
AG-013736 Pfizer melanoma Phase IINew York, NY (see also kidney, lung, pancreatic, (860) 732-7920
other)
Allovectin-7® Vical metastatic melanoma Phase II completedHLA-B7 plasmid/ San Diego, CA (858) 646-1100lipid complex (Orphan Drug)
ALS-357 Advanced Life Sciences melanoma Phase IWoodbridge, IL (630) 739-6744
anti-MART-1 TCR National Cancer Institute melanoma Phase IIretroviral Bethesda, MD N C I T R I A L
vector-transduced (800) 4-CANCERautologous cells
autologous T cells National Cancer Institute melanoma Phase I/IIplus fowlpox Bethesda, MD N C I T R I A L
gp100: P209 Therion Biologics (800) 4-CANCERCambridge, MA
autologous T cells National Cancer Institute melanoma Phase I/IIretrovirally Bethesda, MD N C I T R I A L
transduced IL-2 (800) 4-CANCER
Canvaxin™ CancerVax stage III melanoma Phase IIICarlsbad, CA (760) 494-4200Serono (800) 283-8088Rockland, MA
CP-675,206 Pfizer metastatic melanoma Phase IINew York, NY (see also prostate) (860) 732-7920
depsipeptide National Cancer Institute (see also bladder, brain, colon, Phase II(FK228) Bethesda, MD head/neck, leukemia, lung, N C I T R I A L
Gloucester lymphoma, ovarian, solid tumors, (800) 4-CANCERPharmaceuticals stomach, other)Cambridge, MA
Dimericine® AGI Dermatics treatment of photosensitivity to Phase III completedT4N5 liposomes Freeport, NY ultraviolet rays in patients with (516) 868-9026
xeroderma pigmentosa
EMD 121974 National Cancer Institute (see also brain, prostate, solid Phase IIBethesda, MD tumors) N C I T R I A L
Merck KGaA (800) 4-CANCERDarmstadt, Germany
39M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
S K I N C A N C E RProduct Name Sponsor Indication Development Status
ESO-1:157-165 National Cancer Institute melanoma Phase II(165V) peptide Bethesda, MD N C I T R I A L
vaccine (800) 4-CANCER
fowlpox National Cancer Institute melanoma Phase IIand vaccinia Bethesda, MD (see also solid tumors) N C I T R I A L
TRICOM Therion Biologics (800) 4-CANCERCambridge, MA
Genasense® Genta melanoma Phase IIIoblimersen sodium Berkeley Heights, NJ (see also breast, colon, kidney, (908) 286-9800(G3139) leukemia, lung, lymphoma,
gp100 peptide National Cancer Institute melanoma Phase II/IIIvaccine Bethesda, MD N C I T R I A L
(800) 4-CANCER
gp100 protein National Cancer Institute melanoma Phase I/II(184V) Bethesda, MD N C I T R I A L
(800) 4-CANCER
IMC-GP75 Imclone Systems melanoma Phase INew York, NY (212) 645-1405
INGN 241 Introgen Therapeutics melanoma Phase I/II(mda-7) Austin, TX (see also solid tumors) (512) 708-9310
mage 3 GlaxoSmithKline treatment of melanoma Phase II(249553; Philadelphia, PA (see also lung) (888) 825-5249recombinant Rsch. Triangle Park, NCpharmaccine)
MART-1 National Cancer Institute melanoma Phase II/IIIpeptide vaccine Bethesda, MD N C I T R I A L
Xcytrin® Pharmacyclics solid tumors in combination with Phase Imotexafin Sunnyvale, CA Taxotere® (408) 774-0330gadolinium (see also brain, kidney, leukemia,
lung, lymphoma, multiple myeloma)
Xyotax™ Cell Therapeutics (see also lung, ovarian) Phase Ipolyglutamate Seattle, WA (206) 282-7100paclitaxel
Genasense® Genta gastric cancer Phase IIoblimersen sodium Berkeley Heights, NJ (see also breast, colon, kidney, (908) 286-9800(G3139) leukemia, lung, lymphoma,
GW572016 National Cancer Institute (see also brain, breast, cervical, Phase IIBethesda, MD head/neck, liver, prostate) N C I T R I A L
GlaxoSmithKline (800) 4-CANCERPhiladelphia, PARsch. Triangle Park, NC
HuC242-DM4 ImmunoGen gastric cancer Phase ICambridge, MA (see also colon, pancreatic) (617) 995-2500
Insegia™ Aphton gastric and/or esophageal cancer Phase II completedanti-gastrin 17 Miami, FL (see also pancreatic) (416) 667-2701therapeutic sanofi pasteurvaccine Toronto, Ontario
lapatinib GlaxoSmithKline gastric cancer Phase III(ErbB-2 and EGFR Philadelphia, PA (see also bladder, breast, (888) 825-5249dual kinase Rsch. Triangle Park, NC head/neck, kidney, lung)inhibitor)
LMB-9 IVAX Phase IIMiami, FL (305) 575-6000
OSI-7904L OSI Pharmaceuticals gastric cancer Phase II(thymidylate Melville, NY (800) 572-1932synthase inhibitor)
Taxotere® Sanofi-aventis gastric cancer Phase IIIdocetaxel Bridgewater, NJ (see also head/neck) (800) 633-1610
Xorane IVAX gastric cancer Phase II completedoral paclitaxel Miami, FL (see also breast, lung) (305) 575-6000
C A N C E R / C H E M O T H E R A P Y - R E L A T E D C O N D I T I O N SProduct Name Sponsor Indication Development Status
497115 GlaxoSmithKline thrombocytopenia Phase II(thrombopoietin Philadelphia, PA (888) 825-5249agonist) Rsch. Triangle Park, NC
679769 GlaxoSmithKline chemotherapy-induced nausea Phase II(NK1 antagonist) Philadelphia, PA and vomiting (888) 825-5249
Rsch. Triangle Park, NC
48 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
C A N C E R / C H E M O T H E R A P Y - R E L A T E D C O N D I T I O N SProduct Name Sponsor Indication Development Status99MTc-NC100692 GE Healthcare diagnostic imaging agent for the Phase II
Princeton, NJ detection of angiogenesis (609) 514-6000associated with metastatic disease
APF530 A.P. Pharma prevention of acute and delayed Phase IIRedwood City, CA chemotherapy-induced nausea (650) 366-2626
CyPat™ Duramed Research reduction of moderate to severe Phase IIcyproterone Bala Cynwyd, PA vasomotor associated with surgical (610) 747-2687acetate or chemical castration in prostate
cancer patients
deferasirox Novartis Pharmaceuticals chronic iron overload Phase III(ICL 670) East Hanover, NJ (973) 781-8300
Dynepo™ Transkaryotic Therapies treatment of anemia associated Phase III completedepoietin delta Cambridge, MA with cancer chemotherapy (617) 349-0200(gene-activated erythropoietin)
EF5 National Cancer Institute detection of tumor hypoxia in clinical trialsBethesda, MD (see also cervical, head/neck, N C I T R I A L
CA4P OXiGENE advanced regional or metastatic Phase II(combrestatin) Watertown, MA anaplastic thyroid cancer (ATC) (617) 673-7800
(see also breast, cervical, colon, head/neck, lung, ovarian, prostate)--------------------------------------------------------------------------------------newly diagnosed ATC in Phase I/IIcombination with doxorubicin, (617) 673-7800cisplatin and radiotherapy
CAL Chugai Pharma USA bone metastases in breast cancer Phase I/II(humanized San Diego, CA (858) 535-5900anti-PTHrP MAb)
carboxyamido- National Cancer Institute refractory cancers Phase Itriazole Bethesda, MD (see also lymphoma) N C I T R I A L
(CAI) (800) 4-CANCER
clodronate Berlex Laboratories to reduce the occurrence of bone application submittedMontville, NJ metastases in the adjuvant (973) 487-2222
(post-surgical) treatment of breast cancer
Dacogen™ National Cancer Institute advanced malignancies, Phase I/IIdecitabine Bethesda, MD thyroid cancer N C I T R I A L
MGI Pharma (see also leukemia, lung, (800) 4-CANCERMinneapolis, MN solid tumors)SuperGenDublin, CA
depsipeptide National Cancer Institute advanced malignancies, thyroid Phase I/II(FK228) Bethesda, MD cancer N C I T R I A L
Gloucester (see also bladder, brain, colon, (800) 4-CANCERPharmaceuticals head/neck, leukemia, lung, Cambridge, MA lymphoma, ovarian, skin, solid
tumors, stomach)
epothilone B National Cancer Institute advanced malignancies, germ cell Phase I/IIanalog Bethesda, MD tumors N C I T R I A L
(BMS 247550) Bristol-Myers Squibb (see also brain, breast, kidney, (800) 4-CANCERPrinceton, NJ liver, lymphoma, prostate, solid
tumors)
Genasense® Genta mantle cell cancer Phase IIoblimersen sodium Berkeley Heights, NJ (see also breast, colon, kidney, (908) 286-9800(G3139) leukemia, lung, lymphoma, multiple
RAV12 Raven Biotechnologies metastatic or recurrent Phase I(anti-RAAG12 MAb) South San Francisco, CA adenocarcinoma (650) 624-2600
TACI-Ig Serono relapsed/refractory B-cell Phase IRockland, MA malignancies (800) 283-8088
(see also multiple myeloma)
Y-90 hAFP Immunomedics germ cell cancer Phase I(IMMU-105) Morris Plains, NJ (see also liver) (973) 605-8200
U N S P E C I F I E D C A N C E R S( D R U G S T H A T H A V E P O T E N T I A L F O R O N E O R M O R E O F T H E P R E V I O U S C A N C E R S )Product Name Sponsor Indication Development Status
743921 GlaxoSmithKline Phase I(kinesin spindle Philadelphia, PA (888) 825-5249protein [KSP] Rsch. Triangle Park, NCinhibitor)
ABT-510 Abbott Laboratories Phase IIAbbott Park, IL (847) 936-1189
ABT-751 Abbott Laboratories Phase IIAbbott Park, IL (847) 936-1189
Apo2L/TRIAL Amgen Phase IThousand Oaks, CA (805) 447-1000Genentech (650) 225-1000South San Francisco, CA
E7820 Eisai Phase IRidgefield Park, NJ (201) 403-2500
52 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
U N S P E C I F I E D C A N C E R S( D R U G S T H A T H A V E P O T E N T I A L F O R O N E O R M O R E O F T H E P R E V I O U S C A N C E R S )Product Name Sponsor Indication Development Status
elacridar GlaxoSmithKline Phase I(oral bioenhancer) Philadelphia, PA (888) 825-5249
Rsch. Triangle Park, NC
gallium maltolate Titan Pharmaceuticals Phase ISouth San Francisco, CA (650) 244-4990
IMC-1121b Imclone Systems Phase INew York, NY (212) 645-1405
KRX-0403 Keryx Biopharmaceuticals Phase I completed(spindle poison) New York, NY (212) 531-5965
The content of this survey has been obtained through government and industry sources based on the latestinformation. Survey current as of April 15, 2005. The information may not be comprehensive. For more specificinformation about a particular product, contact the individual company directly. The entire series of Medicines inDevelopment is available on PhRMA’s web site.
PhRMA Internet address: http://www.phrma.org
Provided as a Public Service by PhRMA. Founded in 1958 as the Pharmaceutical Manufacturers Association.
53M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
adenomatous—Relating to adenoma:an ordinarily benign neoplasm ofepithelial tissue in which the tumorcells form glands or glandlike struc-tures in the framework of an organ,gland or other structure.
adjuvant—A substance or drug thataids another substance in its action.
anaplastic thyroid carcinoma—Anaggressive, invasive form of cancer ofthe thyroid gland. It occurs most oftenin people over age 60. The cause isunknown. Anaplastic cancer accountsfor only about 1 percent of all thyroidcancers and is a very rare disease.
angiogenesis—The physiologicalprocess involving the formation ofnew blood vessels from pre-existingvessels. This is a normal process ingrowth and development, as well asin wound healing. However, this isalso a fundamental step in the transi-tion of tumors from a dormant stateto a malignant state.
application submitted—An applica-tion for marketing has been submittedby the company to the Food andDrug Administration (FDA).
autologous—In blood transfusion andtransplantation, a situation in whichthe donor and recipient are the sameperson. An autologous graft is pro-viding a graft, for example of skin,to yourself.
B cell—A class of white blood cellsimportant to the body’s immunesystem.
BCG—Bacillus Calmette-Guérin.Immunotherapy for bladder cancer.
carcinoma—A malignant tumor thatarises from epithelial tissues, suchas skin.
cervical—Relating to the neck ofthe uterus.
curative therapy—Therapy thatattempts permanent control of a tumor
using aggressive but not excessivelydebilitating treatments. Multiple treat-ment modalities are often employed.
cutaneous—Pertaining to the skin.
emesis—Vomiting.
familial adenomatous polyposis (FAP)—A colon cancer predispositionsyndrome in which hundreds tothousands of precancerous colonicpolyps develop, beginning at a meanage of 16. By age 35, 95 percent ofindividuals with FAP have polyps.Without colectomy, colon cancer isinevitable. The mean age of coloncancer in untreated individuals is 39years. Familial adenomatous polypo-sis is caused by a genetic mutation.In the United States, estimates varyfrom 1 case in 6,850 people to 1 casein 31,250 people.
gastric—Of or relating to the stomach.
glioblastoma multiforme—A fastgrowing and highly malignant typeof brain tumor arising from glial(supporting) cells within the brain.There are about five to 10 newcases per million population peryear in the United States, and thecause is unknown.
glioma—A type of brain tumor arisingfrom the supporting glial cells withinthe brain. Gliomas make up about60 percent of all primary brain tumorsand are frequently malignant.
graft vs. host disease (GVHD)—Acomplication in bone marrow trans-plants where immune system cellsattack the transplant recipient’s tissues.
hepatocellular cancer/carcinoma—A cancer that begins in the liver cells.
imaging agent—A substance used toenhance x-ray images of organs andspaces in the body.
immunotoxin—A hybrid moleculecreated by coupling an antibody orantigen with part or all of a toxin. The
hybrid molecule combines the speci-ficity of the antibody or antigen withthe toxicity of the toxin. The possibletargets of immunotoxins include can-cer cells and cells containing HIV.
intratumoral—Within a tumor.
islet cell cancer—A rare cancer inwhich malignant cells are found incertain tissues of the pancreas. Thepancreas has two basic jobs in thebody. It produces digestive juicesthat help break down (digest) foodand hormones (such as insulin) thatregulate how the body stores anduses food. The area of the pancreasthat produces digestive juices iscalled the exocrine pancreas. About95 percent of pancreatic cancersbegin in the exocrine pancreas. Thehormone-producing area of the pan-creas has special cells called isletcells and is called the endocrinepancreas. Only about 5 percent ofpancreatic cancers start there.
Kaposi’s sarcoma—A rare, malignantskin tumor that occurs in some AIDSpatients. It can be accompanied byfever, enlarged lymph nodes andgastrointestinal problems.
leukemia—A form of cancer in whichabnormally growing white blood cellsare scattered throughout the body andbone marrow. They can take over themarrow and prevent it from makingenough normal blood cells (white,red and platelets), leaving the patienthighly susceptible to serious infec-tions, anemia and bleeding episodes.The cells can also spill into the blood,infiltrating and interfering with thefunction of other organs. The fourmain types of leukemia are: acutelymphoblastic leukemia (ALL), acutemyelogenous leukemia (AML), chroniclymphocytic leukemia (CLL), andchronic myelogenous leukemia (CML).The acute types have a rapid onset,and overwhelming infection or bloodloss can cause death. The chronicforms progress much more slowly.
G l o s s a r y
54 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
lung cancer—The leading cause of cancer deaths in both men andwomen. There are several types oflung cancer, the most common beingsquamous cell carcinoma, small (oat)cell carcinoma, adenocarcinoma andlarge cell carcinoma. Each has a dif-ferent growth pattern and response totreatment. The squamous cell, smallcell and large cell types are all stronglyassociated with tobacco abuse.
lymphoma—Cancers in which thecells of lymphoid tissue, found mainlyin the lymph nodes and spleen, mul-tiply unchecked. Lymphomas fall intotwo categories: Hodgkin disease,characterized by a particular kindof abnormal cell, and non-Hodgkinlymphomas, which vary in theirmalignancy according to the natureand activity of the abnormal cells.Mantle cell lymphoma is a type ofnon-Hodgkin lymphoma.
melanoma—A cancer made up ofpigmented (usually brown-colored)skin cells anywhere in the body.
mesothelioma—A tumor of the lin-ing of the lung and chest cavity (thepleura).
metastases/metastatic—Areas ofsecondary cancer that have spreadfrom the primary or original cancersite.
mucositis—The swelling, irritation,and ulceration of the mucosal cellsthat line the digestive tract. Mucositiscan occur anywhere along the diges-tive tract from the mouth to the anus.It can be a very troublesome andpainful side effect of chemotherapy.
multiple myeloma—A malignantcondition of middle to old age,characterized by the uncontrolledproliferation and disordered functionof plasma cells in the bone marrow.The condition, which makes thepatient particularly prone to infection,is rare, with about three new casesannually per 100,000 population.
myelodysplastic syndromes (MDS)—Blood disorders that ultimately arefatal. Patients usually succumb toinfections or bleeding. The term“preleukemia” has been used todescribe these disorders.
Phase I—Safety testing and pharma-cological profiling of new drugs inhumans.
Phase II—Effectiveness testing andidentification of side effects of newdrugs in humans.
Phase IV—Additional post-marketingtesting of drugs required by the FDA.
photodynamic therapy (PDT)—Atreatment that uses a drug, called aphotosensitizer or photosensitizingagent, and a particular type of light.When photosensitizers are exposedto a specific wavelength of light,they produce a form of oxygen thatkills nearby cancer cells.
potentiate—To make potent or pow-erful; to enhance or increase theeffect of (a drug); to promote orstrengthen (a biochemical or physio-logical action or effect).
prostatic intraepithelial neoplasia(PIN)—A precursor lesion to prostatecancer. It has been estimated that 30percent of men with high-grade PINdevelop clinical evidence of prostatecancer within a year.
refractory—Resistant to treatment orcure.
rhabdomyosarcoma—A malignantneoplasm derived from skeletal(striated) muscle.
sarcoma—A malignant tumor thatarises from deep body tissues, suchas muscle, bone or fibrous tissue.
stereotactic radiosurgery (SRS)—Away of treating brain disorders with aprecise delivery of a single high dose
of radiation in a one-day session.Treatment involves the use of focusedradiation beams delivered to a specificarea of the brain to treat abnormalities,tumors or other functional disorders.Stereotactic radiosurgery is limited tothe head and neck as these areas canbe immobilized with skeletal fixationdevices that completely restrict thehead’s movement, permitting the mostprecise and accurate treatment.
T cell—One of two main classes ofwhite blood cells called lymphocytes,which are important to the body’sdisease-fighting immune system.
thrombocytopenia—A reduction inthe number of platelet cells in theblood, which causes a tendency tobleed, especially from the smallerblood vessels.
vasomotor—Relating to the nervesand muscles that cause the bloodvessels to constrict or dilate.
Waldenstrom’s macroglobulinemia—A rare, chronic cancer that is clas-sified as a plasma cell neoplasm. Itaffects plasma cells, which developfrom white blood cells called B-lym-phocytes or B cells. In Waldenstrom’smacroglobulinemia, abnormal plasmacells multiply out of control. Theyinvade the bone marrow, lymph nodes,and spleen and produce excessiveamounts of an antibody called IgM.Excess IgM in the blood causes hyper-viscosity (thickening) of the blood. Inextreme cases, the increased concen-tration of IgM in the blood can leadto heart failure. The disease usuallyoccurs in people over age 65 but canoccur in younger people. It is morecommon among men than womenand among whites than blacks.
xeroderma pigmentosa—A rare,inherited skin disease caused byextreme sensitivity to sunlight,which causes the skin to becomedry, wrinkled, freckled and prema-turely aged by about the age of five.Various types of benign and malig-nant skin tumors also develop.
G l o s s a r y
55M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
S E L E C T E D F A C T S A B O U T C A N C E R I N T H EU N I T E D S T A T E SOverview1
• Cancer is the second leading cause of death by disease—1 of every 4 deaths—in the United States, exceeded only by heart disease. This year about 570,280 Americans are expected to die of cancer, more than 1,500 people a day.
• In 2005, nearly 1.4 million new cancer cases are expected to be diagnosed. Since 1990, more than 17 millionnew cancer cases have been diagnosed. The National Cancer Institute estimates that approximately 9.8 millionAmericans with a history of cancer were alive in January 2001. The 5-year relative survival rate for all cancersdiagnosed between 1995 and 2000 is 64 percent, up from 50 percent in the mid-70s.
• Men have a little less than a 1 in 2 lifetime risk of developing cancer, and for women the risk is a little morethan 1 in 3. About 76 percent of all cancers are diagnosed in people ages 55 and older.
Costs1
• The National Institutes of Health estimate overall costs for cancer in 2004 at $189.8 billion: $69.4 billion fordirect medical costs (total of all health expenditures); $16.9 billion for indirect morbidity costs (cost of lostproductivity due to illness); and $103.5 billion for indirect mortality costs (cost of productivity due topremature death).
Bladder (Urinary) Cancer1
• Overall, bladder cancer incidence is nearly four times higher in men than in women and two times higher inwhites than in African Americans.
Breast Cancer1
• Breast cancer, the most frequently diagnosed cancer in women, ranks second among cancer deaths in women(after lung cancer). Mortality rates declined by 2.3 percent per year from 1990 to 2001, with larger decreases inyounger (under age 50) women due to increased awareness, earlier detection, and improved treatment.
Cervical Cancer/Uterine (Endometrial) Cancer1
• An estimated 10,370 cases of invasive cervical cancer are expected to be diagnosed in 2005. Incidence rates havedecreased steadily over the past several decades in both white and African-American women. Mortality rates havealso declined steadily; an estimated 3,710 cervical cancer deaths are expected in 2005.
• Nearly 41,000 cases of cancer of the uterine corpus (body of the uterus), usually of the endometrium or lining ofthe uterus, are expected to be diagnosed in 2005. After increasing from 1988 to 1998, incidence rates leveled offthrough 2001.
Colorectal Cancer1
• An estimated 104,950 colon and 40,340 rectal cancer cases are expected to occur in 2005. Colorectal cancer isthe third most common cancer in men and women.
• The primary risk factor for colorectal cancer is age; more than 90 percent of cases are diagnosed in people overage 50.
Leukemia1
• An estimated 34,810 new leukemia cases are expected in 2005, with slightly more acute (15,930) than chronic(14,330) forms of the disease.
• Although often thought of as primarily a childhood disease, leukemia is diagnosed 10 times more often in adultsthan in children. Acute lymphocytic leukemia accounts for approximately 78 percent of the leukemia casesamong children. In adults, the most common types are acute myeloid leukemia (about 10,980 cases) andchronic lymphocytic leukemia (about 8,900 cases).
Lung Cancer1
• Lung cancer is the leading cause of cancer death in men and women. The estimated 163,510 deaths expectedthis year will account for about 29 percent of all cancer deaths. Death rates have continued to decline significantlyin men since 1991 by about 1.9 percent per year.
56 M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
S E L E C T E D F A C T S A B O U T C A N C E R I N T H EU N I T E D S T A T E SLung Cancer1 (continued)
• Since 1987, more women have died each year of lung cancer than from breast cancer. Female lung cancer deathrates have recently reached a plateau after continuously increasing for several decades.
Lymphoma1
• Of the estimated 63,740 new cases of lymphoma this year, 7,350 will be Hodgkin lymphoma and 56,390 will be non-Hodgkin lymphoma (NHL). Since the early 1970s, incidence rates for NHL nearly doubled, but morerecently those rates stabilized due primarily to the decline in AIDS-related NHL. Overall, incidence rates forHodgkin lymphoma have declined significantly since 1990 at a rate of 1.2 percent per year.
Ovarian Cancer 1
• The estimated 22,220 new cases of ovarian cancer expected this year would account for about 3 percent of allcancers among women. It ranks second among gynecologic cancers, following cancer of the uterine corpus.
• Ovarian cancer causes more deaths than any other cancer of the female reproductive system—more than 16,000deaths are expected in 2005.
Pain
• While not all people with cancer experience pain, it is common in cancer patients. Up to 50 percent of peoplewith cancer experience pain while undergoing treatment, and 70 percent to 90 percent of people with advancedcancer experience pain.2
• The most common cancer pain is from tumors that metastasize to the bone. Up to 80 percent of cancer patientswith bone metastasis experience pain. The second most common cancer pain, and perhaps the most severe, iscaused by tumors infiltrating the nerve and hollow viscus. The third most common pain associated with canceroccurs as a result of chemotherapy, radiation, or surgery.3
Prostate Cancer 1
• Prostate cancer is the second leading cause of cancer death in men, and an estimated 30,350 are expected todie this year. Although death rates have been declining among both white and African-American men since theearly ‘90s, rates in African-American men remain more than twice as high as rates in white men.
Skin Cancer 1
• The most serious form of skin cancer is melanoma, which is expected to be diagnosed in nearly 60,000 peoplein 2005. During the 1970s, the incidence rate of melanoma increased rapidly by about 6 percent per year.Since 1981, the rate of increase slowed to a little less than 3 percent a year.
New Cancer Cases/Deaths 1
Cancer Type Estimated 2005 New Cases Estimated 2005 Deaths
All Sites 1,372,910 570,280Male 710,040 295,280Female 662,870 275,000
Ovarian Cancer 22,220 16,210Male — —Female 22,220 16,210
Pancreatic Cancer 32,180 31,800Male 16,100 15,820Female 16,080 15,980
Prostate Cancer 232,090 30,350Male 232,090 30,350Female — —
Stomach Cancer 21,860 11,550Male 13,510 6,770Female 8,350 4,780
Sources:1. Cancer Facts & Figures 2005, American Cancer Society (www.cancer.org)2. Cancer-Pain.org (www.cancer-pain.org)3. Oncology Channel (www.oncologychannel.com)
59M E D I C I N E S I N D E V E L O P M E N T F O R Cancer 2005
T H E D R U G D I S C O V E R Y , D E V E L O P M E N T A N D A P P R O V A L P R O C E S S
It takes 10-15 years on average for an experimental drug to travel from the lab to U.S. patients.Only five in 5,000 compounds that enter preclinical testing make it to human testing. One of these five tested in people is approved.
The U.S. system of new drug approvals is perhapsthe most rigorous in the world.
It takes 10–15 years, on average, for an experimentaldrug to travel from lab to U.S. patients, according tothe Tufts Center for the Study of Drug Development,based on drugs approved from 1994 through 1998.Only five in 5,000 compounds that enter preclinicaltesting make it to human testing. And only one of thosefive is approved for sale.
On average, it costs a company $802 million toget one new medicine from the laboratory to U.S.patients, according to a November 2001 report by theTufts Center for the Study of Drug Development.
Once a new compound has been identified in thelaboratory, medicines are developed as follows:
Preclinical Testing. A pharmaceutical companyconducts laboratory and animal studies to showbiological activity of the compound against thetargeted disease, and the compound is evaluated forsafety.
Investigational New Drug Application (IND). Aftercompleting preclinical testing, a company files an INDwith the U.S. Food and Drug Administration (FDA) tobegin to test the drug in people. The IND becomeseffective if FDA does not disapprove it within 30 days.The IND shows results of previous experiments; how,where and by whom the new studies will beconducted; the chemical structure of the compound;how it is thought to work in the body; any toxiceffects found in the animal studies; and how thecompound is manufactured. All clinical trials must bereviewed and approved by the Institutional ReviewBoard (IRB) where the trials will be conducted.Progress reports on clinical trials must be submitted atleast annually to FDA and the IRB.
Clinical Trials, Phase I. These tests involve about20 to 100 normal, healthy volunteers. The tests study adrug’s safety profile, including the safe dosage range.The studies also determine how a drug is absorbed,distributed, metabolized, and excreted as well as theduration of its action.
Clinical Trials, Phase II. In this phase, controlledtrials of approximately 100 to 500 volunteer patients(people with the disease) assess a drug’s effectiveness.
Clinical Trials, Phase III. This phase usually involves 1,000 to 5,000 patients in clinics and hospitals.Physicians monitor patients closely to confirm efficacyand identify adverse events.
New Drug Application (NDA)/Biologic LicenseApplication (BLA). Following the completion of allthree phases of clinical trials, a company analyzes allof the data and files an NDA or BLA with FDA if thedata successfully demonstrate both safety andeffectiveness. The applications contain all of thescientific information that the company has gathered.Applications typically run 100,000 pages or more.The average review time for the 36 new therapeuticsapproved by the FDA in 2004 was 18.1 months.
Approval. Once FDA approves an NDA or BLA, thenew medicine becomes available for physicians toprescribe. A company must continue to submitperiodic reports to FDA, including any cases ofadverse reactions and appropriate quality-controlrecords. For some medicines, FDA requires additionaltrials (Phase IV) to evaluate long-term effects.
Discovering and developing safe and effective newmedicines is a long, difficult, and expensive process.PhRMA member companies invested an estimated$38.8 billion in research and development in 2004.
Clinical Trials
Discovery/ Phase Phase Phase PhasePreclinical Testing I II III FDA IV
Years
TestPopulation
Purpose
SuccessRate
6.5
Laboratory andanimal studies
Assess safety,biological
activity andformulations
5,000compounds evaluated
1.5
20 to 100healthy
volunteers
Determinesafetyand
dosage
2
100 to 500patient
volunteers
Evaluateeffectiveness,
look forside effects
1.5
Reviewprocess/approval
1approved
Additionalpost-
marketingtesting
requiredby FDA
3.5
1,000 to 5,000patient
volunteers
Confirm effectiveness,monitor adversereactions from long-term use
5enter trials
File
IND
atFD
A
File
ND
A/BL
Aat
FDA
T H E D R U G D E V E L O P M E N T A N D A P P R O V A L P R O C E S S
New Medicines. New Hope.®
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www.phrma.org 5/05
Medicines in Development for Cancer is presented by PhRMA in cooperation with the following organizations:
Being listed in this report in no way implies that the above-mentioned organizations endorse or recommend the use of any of the products in development contained in this publication. For further information, patients should consulttheir physicians or health care providers.
American Academy of Otolaryngology–Head and Neck Surgery
American Academy of Physician AssistantsAmerican Association for Cancer EducationAmerican Association for Cancer ResearchAmerican Brain Tumor AssociationAmerican Cancer SocietyAmerican Nurses AssociationAmerican Pain SocietyAmerican Society for Therapeutic Radiology and
Oncology (ASTRO)American Society of Clinical OncologyAssociation of American Cancer InstitutesAssociation of Community Cancer CentersBreast Cancer Research FoundationBurger King Cancer Caring CenterCancer ActionCancer CareCancer Research and Prevention FoundationCancer Research InstituteCandlelighters Childhood Cancer FoundationChemotherapy FoundationFlorida Hospital Cancer InstituteInteramerican College of Physicians & SurgeonsInternational Cancer Alliance for Research and
Education
International Myeloma FoundationKidney Cancer AssociationLeukemia and Lymphoma SocietyLymphoma Research FoundationNational Alliance for Hispanic HealthNational Black Nurses AssociationNational Brain Tumor FoundationNational Cancer InstituteNational Cervical Cancer CoalitionNational Childhood Cancer FoundationNational Chronic Pain Outreach AssociationNational Coalition for Cancer SurvivorshipNational Foundation for Cancer ResearchNational Medical AssociationNational Prostate Cancer CoalitionOncology Nursing SocietyPatient Advocates for Advanced Cancer Treatments
(PAACT)People Living Through CancerSkin Cancer FoundationUs TOO International Prostate Cancer Education and
Support NetworkV Foundation for Cancer ResearchY-ME National Breast Cancer Organization
