New drug information ● Rubraca ™ (rucaparib): The U.S. Food and Drug Administration (FDA) granted accelerated approval to Clovis Oncology, Inc.’s Rubraca (rucaparib) for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test. The FDA approved Rubraca under its accelerated approval program based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. New indications ● Iclusig ® (ponatinib): The FDA has granted full approval of Ariad’s Iclusig for adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated; and for the treatment of adult patients with T315I- positive CML (chronic phase, accelerated phase, or blast phase) or T315I positive Ph+ ALL. Iclusig was initially approved under the FDA’s accelerated approval program which allows patients access to new drugs that treat serious conditions while the company conducts studies to prove clinical benefit. ● Avastin ® (bevacizumab): Genentech’s Avastin has been approved in combination with chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Prior to this approval, Avastin was approved for use in these same cancers with platinum-resistance in combination with chemotherapy; as well as other cancer diagnosis. While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner. Specialty Pipeline Update D Drug Insights > December 2016
Transcript
New drug information ● Rubraca™ (rucaparib): The U.S. Food and Drug
Administration (FDA) granted accelerated approval to Clovis Oncology, Inc.’s Rubraca (rucaparib) for women with advanced ovarian cancer who have been treated with two or more chemotherapies and whose tumors have a specific gene mutation (deleterious BRCA) as identified by an FDA-approved companion diagnostic test. The FDA approved Rubraca under its accelerated approval program based on objective response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
New indications ● Iclusig® (ponatinib): The FDA has granted full approval
of Ariad’s Iclusig for adult patients with chronic phase, accelerated phase, or blast phase chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) for whom no other tyrosine kinase inhibitor (TKI) therapy is indicated; and for the treatment of adult patients with T315I-positive CML (chronic phase, accelerated phase, or blast phase) or T315I positive Ph+ ALL. Iclusig was initially approved under the FDA’s accelerated approval program which allows patients access to new drugs that treat serious conditions while the company conducts studies to prove clinical benefit.
● Avastin® (bevacizumab): Genentech’s Avastin has been approved in combination with chemotherapy, followed by Avastin alone, for the treatment of patients with platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer. Prior to this approval, Avastin was approved for use in these same cancers with platinum-resistance in combination with chemotherapy; as well as other cancer diagnosis.
While the information in this newsletter is from sources we believe to be reliable, we do not warrant that the information in this document is free from error. Use it only as a guide. Statements regarding drugs or manufacturers are not intended as promotion; those statements should not be used to make assumptions about formulary status. Each trademarked drug name is the property of its respective owner.
Specialty Pipeline Update
D Drug Insights > December 2016
Specialty Pipeline > December 2016 Page 2
December news ● “AstraZeneca’s (AZ) lung cancer medication, Tagrisso®
(osimertinib), a blockbuster hopeful and important pillar in the company’s big sales ambitions, soundly beat chemotherapy in a new phase 3 trial, staving off cancer growth for more than twice as long as the older regimen. The results have AZ execs talking up their case for Tagrisso as a new standard of care in certain patients.”1
● “Novartis’ Sandoz unit has been marketing Zarxio®, its biosimilar version of Amgen’s blockbuster drug Neupogen®, for more than a year, but the drug is still tangled in a patent fight that boils down to one central question: Should biosimilar makers have to give six months’ notice to the original drugmaker after they receive FDA approval for their copycat version? The answer will affect not only Novartis and Amgen, but any company seeking to make a biosimilar product.”2
Specialty Pipeline > December 2016 Page 3
Specialty new product approvals in the past 12 months
Generic name Brand name Manufacturer Indication(s)Route of administration Date approved*
adalimumab-otto Amjevita™ Amgen Several inflammatory diseases; biosimilar to Humira® (adalimumab)
Intravenous infusion
October 2016
eteplirsen Exondys 51™ Sarepta Therapeutics Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation in the DMD gene that is amenable to exon 51 skipping
Intravenous infusion
September 2016
immune globulin (human), 20% solution
Cuvitru™ Shire/Baxalta Primary immunodeficiency in adults and pediatric patients aged two and older
Subcutaneous infusion
September 2016
etanercept-szzs Erelzi™ Sandoz Several autoimmune diseases; biosimilar to Enbrel® (etanercept)
Subcutaneous injection
August 2016 Launch delayed until late 2018 or beyond.
sofosbuvir/velpatasvir Epclusa® Gilead Hepatitis C (all genotypes) Oral June 2016
daclizumab high-yield process Zinbryta™ Biogen and AbbVie Multiple sclerosis Subcutaneous injection
May 2016
obeticholic acid Ocaliva™ Intercept Primary biliary cholangitis Oral May 2016
recombinant Factor VIII single chain
Afstyla™ CSL Behring Hemophilia A Intravenous infusion
May 2016
infliximab Remsima™ Celltrion/Pfizer Rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis; biosimilar to Remicade®
Intravenous infusion
April 2016
emtricitabine/tenofovir alafenamide
Descovy® Gilead HIV Oral April 2016
defibrotide Defitelio® Jazz Hepatic veno-occlusive disease (VOD) following a hematopoietic stem cell transplant
Intravenous infusion
March 2016
reslizumab Cinqair™ Teva Severe eosinophilic asthma Intravenous infusion
coagulation Factor IX Idelvion® CSL Behring Hemophilia B Intravenous infusion
March 2016
octocog alfa Kovaltry™ Bayer Hemophilia A Intravenous infusion
March 2016
tofacitinib Xeljanz® XR Pfizer Rheumatoid arthritis Oral February 2016
grazoprevir/elbasvir Zepatier™ Merck Hepatitis C (genotypes 1 and 4)
Oral January 2016
Specialty Pipeline > December 2016 Page 4
New indications for approved specialty productsGeneric name Brand name Manufacturer Indication(s) Date approved*
etanercept Enbrel® Amgen For pediatric patients aged 4 or older with chronic moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy; prior approval was only for adults aged 18 and older
lumacaftor/ivacaftor Orkambi® Vertex Pharmaceuticals Treatment of cystic fibrosis in patients aged 6 and older who are homozygous for the F508del mutation in the CFTR gene
Lower limb spasticity in pediatric patients aged 2 and older
August 2016
ombitasvir, paritaprevir, ritonavir, dasabuvir
Viekira XR™ AbbVie, Enanta New once-daily formulation of the direct-acting antiviral combination for treatment of chronic hepatitis C virus 1 in patients with or without compensated cirrhosis; used in combination with twice-daily ribavirin for genotype 1a patients and without ribavirin for genotype 1b patients
darunavir Prezista® Janssen HIV infection in pregnant women July 2016
evolocumab Repatha® Amgen Once monthly dose (420 mg) administered as a single injection
July 2016
omalizumab Xolair® Roche Moderate to severe persistent asthma in children aged 6 to 11
July 2016
adalimumab Humira® AbbVie Non-infectious intermediate, posterior, and panuveitis
July 2016
alpha-1 proteinase inhibitor [human]
Glassia™ Shire and Kamada Self-administration for alpha 1-antitrypsin deficiency in people who have symptoms of emphysema
June 2016
ledipasvir/sofosbuvir Harvoni® Gilead Liver transplant recipients with genotype 1 or 4 infection without cirrhosis or with compensated cirrhosis, and for genotype 1-infected patients with decompensated cirrhosis
February 2016
daclatasvir Daklinza™ Bristol-Myers Squibb Chronic hepatitis C virus (HCV) in patients co-infected with HIV, and for HCV patients with advanced cirrhosis, including decompensated cirrhosis and patients with post-liver transplant recurrence of HCV genotype 1 infection; approved for use in combination with Sovaldi® (sofosbuvir)
February 2016
onabotulinumtoxinA Botox® Allergan Adults with lower limb spasticity January 2016
secukinumab Cosentyx® Novartis Adult patients with active ankylosing spondylitis and active psoriatic arthritis
January 2016
Specialty Pipeline > December 2016 Page 5
Oncology product approvals in the past twelve months
Generic Name Brand Name Manufacturer Indication(s)Route of Administration Date Approved
rucaparib Rubraca™ Clovis Advanced ovarian cancer with deleterious BRCA
New indications for approved oncology drugsGeneric name Brand name Manufacturer New Indication(s) Date approved*
bevacizumab Avastin® Genentech Platinum-sensitive recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer; approved for use in combination with chemotherapy, followed by Avastin alone
December 2016
daratumumab Darzalex® Janssen Treatment of patients with multiple myeloma who have received at least one prior therapy; approved for use in combination with lenalidomide and dexamethasone, or bortezomib and dexamethasone
November 2016
nivolumab Opdivo® BMS Metastatic or recurrent squamous cell carcinoma of the head and neck following disease progression on, or after, platinum-based therapy
November 2016
pembrolizumab Keytruda® Merck Metastatic NSCLC in which tumors express PD-L1 as determined by an FDA-approved test; approval also expands the indication in second-line treatment of lung cancer to include all patients with PD-L1-expressing NSCLC
November 2016
erlotinib Tarceva® Genentech Metastatic non-small cell lung cancer (NSCLC); limited to patients whose tumors have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by a FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least 1 prior chemotherapy regimen
November 2016
atezolizumab Tecentriq® Roche Metastatic non-small cell lung cancer (NSCLC) patients who have progressed during or following platinum-containing chemotherapy
October 2016
blinatumomab Blincyto® Amgen Pediatric and adolescent patients with Philadelphia chromosome-negative (Ph-) relapsed or refractory B-cell precursor acute lymphoblastic leukemia
August 2016
ofatumumab Arzerra® Novartis, Genmab Relapsed chronic lymphocytic leukemia for the anti-CD20 monoclonal antibody; approved for use in combination with fludarabine and cyclophosphamide
August 2016
pembrolizumab Keytruda® Merck For head and neck cancer August 2016
continued
Specialty Pipeline > December 2016 Page 6
Generic name Brand name Manufacturer New Indication(s) Date approved*
nivolumab Opdivo® Bristol-Myers Squibb Hodgkin Lymphoma that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and posttransplantation brentuximab vedotin (Adcetris)
May 2016
lenvatinib Lenvima® Eisai Advanced renal cell carcinoma in patients previously treated with an anti-angiogenic therapy
May 2016
ibrutinib Imbruvica® AbbVie and Johnson & Johnson
Relapsed or refractory chronic lymphocytic leukemia and small lymphocytic leukemia; approved for use in combination with bendamustine and Rituxan® (rituximab)
May 2016
afatinib Gilotrif ™ Boehringer Ingelheim Advanced squamous cell carcinoma of the lung with progression after first-line chemotherapy
April 2016
crizotinib Xalkori® Pfizer Non-small cell lung cancer in patients with the ROS-1 gene mutation
March 2016
obinutuzumab Gazyva® Genentech Follicular lymphoma; approved for use in combination with bendamustine followed by obinutuzumab alone
March 2016
everolimus Afinitor® Novartis Inoperable, locally advanced or metastatic neuroendocrine tumors
March 2016
palbociclib Ibrance® Pfizer Hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer; approved for use in combination with fulvestrant
March 2016
nivolumab Opdivo® Bristol-Myers Squibb BRAF V600 wild-type and BRAF V600 mutation-positive unresectable or metastatic melanoma; approved for use in combination with Yervoy®
January 2016
eribulin mesylate Halaven® Eisai Second-line treatment of liposarcoma January 2016
Specialty Pipeline > December 2016 Page 7
Pipeline watch
Generic Name Brand Name Manufacturer Indication(s)Route of Administration
All brand names are property of their respective owners.
Watch listCriteria for inclusion on the watch list include: Drug is submitted to the FDA and is anticipated to have material impact to trend and/or material impact to preferred product strategies (medical or pharmacy).
