Specialty Drug Approvals-2014 Highlights + 2015 Projections

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Specialty Drug Approvals

2014 HIGHLIGHTS + 2015 PROJECTIONS

cl inical services

INDUSTRY AND MARKET DATACertain information contained in this document concerning our industry and the markets in which we operate is based on information from publicly available independent industry and research organizations and other third-party sources, and management estimates. Management estimates are derived from publicly available information released by independent industry and research analysts and third-party sources, as well as data from our internal research, and are based on assumptions made by us upon reviewing such data and our knowledge of such industry and markets, which we believe to be reasonable. We believe the data from these third-party sources is reliable. In addition, projections, assumptions and estimates of the future performance of the industry in which we operate and our future performance are necessarily subject to uncertainty and risk due to a variety of factors, as discussed in Diplomat’s reports filed with the Securities and Exchange Commission. These and other factors could cause results to differ materially from those expressed in the estimates made by these third-party sources. Diplomat assumes no obligation to publicly update the statements contained herein, which are made as of the date hereof or the earlier date specified herein, whether as a result of new information, future developments or otherwise.

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AT D I PLOM AT,

we blend clinical excellence

with a personal touch

—

for happier lives

and health that lasts.

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Proprietary information of Diplomat Pharmacy Inc. Subject to change without notice. Copyright © 2015 by Diplomat Pharmacy Inc. All rights reserved.

2014 WAS AN EVENTFUL YEAR for new drug approvals. The

Food and Drug Administration (FDA) Center for Drug Evaluation

and Research (CDER) approved 41 novel new drugs. This is

the highest total since 1996 and is well above the average of

approximately 25 approvals per year during the last decade. It’s

noteworthy that 17 of these 41 drugs (41 percent) were the first

drug of their class to earn approval.1

Certain particularly promising drugs pose a significant improvement over

currently available therapies. For these drugs, the FDA has developed four

designations: Accelerated Approval, Breakthrough, Fast Track and Priority

Review. These designations allow for expedited development through

clinical trials and/or an accelerated FDA review. Of the 41 novel new drugs

approved this past year, 27 (66 percent) earned at least one of these special

designations, evidence of innovative drug development.1

Approximately half of the drug approvals in 2014 meet routinely used criteria

for specialty agents—though no universal definition for what constitutes a

specialty drug exists. Of the specialty agents approved in 2014, the disease

states with the most approvals were rare diseases (11*) and oncology

(eight).1,2

* Includes hemophilia factor products that are not reflected in the CDER approval total, but are considered specialty agents.

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IN TERMS OF DRUG APPROVAL SIGNIFICANCE, 2014

may be remembered most for the approvals for the treatment of chronic

hepatitis C (CHC). The early game changers, simeprevir (Olysio®) and

sofosbuvir (Sovaldi®), were approved in late 2013, but their impact on the

CHC landscape was immense in 2014. Gilead’s combination of Sofosbuvir

and ledipasvir (Harvoni®), along with AbbVie’s Viekira Pak™, were approved in

2014 and have significantly changed the way CHC is treated.

They have also been front and center at the debate over drug cost and

reimbursement sustainability issues. Some drugs that were key components

of CHC therapy not so long ago are now obsolete. The American Association

for the Study of Liver Diseases (AASLD) no longer recommends Incivek®

or Victrelis® for patients of any genotype or treatment status,3 and Vertex

stopped distribution of Incivek® in October 2014.

In oncology, the most interesting class of drugs to gain approval is the

programmed cell death-1 (PD-1) inhibitors. Pembrolizumab (Keytruda®)

from Merck and nivolumab (Opdivo®) by Bristol-Myers Squibb each earned

approvals for late-line melanoma treatment in 2014. They are demonstrating

impressive clinical trial results in a number of other cancers, including lung,

liver, and brain cancers, as well as hematological malignancies. Expanded

indications in 2015 and beyond are likely to be highly influential in the

oncology market space.4

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2014 WAS THE HIGHEST YEAR ON RECORD for rare

disease drug approvals.1 Rare diseases have developed into an intriguing

landscape. For many diseases, limited or—in some cases—no available

therapies exist and manufacturers have found the opportunity to meet

the need for treatment. Examples of this in 2014 are the two new agents

approved for idiopathic pulmonary fibrosis (IPF): pirfenidone (Esbriet®) from

InterMune and nintedanib (Ofev®) by Boehringer Ingelheim.1

2015 IS EXPECTED TO share several similarities with last year. The

oncology and rare-disease pipelines remain strong and several approvals are

expected in each area. CHC still has a few promising drugs in development,

but the time of greatest innovation in that area may have already peaked. The

issue of increasing cost of drugs and payors’ ability to sustain those costs is

certainly not going away. These issues will only intensify as additional high-

cost drugs become available. The percentage of drugs approved that have

earned special FDA designations is expected to remain high as well.

In 2015, oncology is forecasted to see approvals for approximately 10–12

new agents over the course of the year, along with some significant expanded

indications for a few currently available therapies. Rare-disease drugs are

estimated to gain a total of about seven to eight new approvals for

diseases, including:

• Amyloidosis

• Cystic fibrosis

• Duchenne muscular dystrophy

• Familial chylomicronemia

• Hemophilia

• Hypophosphatasia

• Lysosomal lipase deficiency

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Immunology is expected to see fewer approvals compared to rare diseases

and oncology, but the interleukin-17 (IL-17) class of drugs, including

secukinumab, brodalumab and ixekizumab, are expected to have a significant

impact on the psoriasis market.4

Biosimilars will likely be available in the U.S. in 2015, as the first approvals

under the new FDA biosimilar pathway are expected this year. A biosimilar

filgrastim is likely to be the first approved through this new pathway. A

biosimilar epoetin alfa is not far behind.4 Due to uncertainty surrounding

biosimilar regulations in the U.S., questions of interchangeability with the

brand reference products, as well as patient and prescriber preferences, it is

difficult to determine the exact impact these agents will have or when they will

be approved. However, due to the number of highly prescribed biologics with

recently expired or soon-to-be-expiring patents, biosimilars in the U.S. will be

worth watching in 2015 and beyond.

2014 WAS REMARKABLE for the quantity and innovative nature

of the drugs brought to market. Though we can’t be sure what 2015 has

in store, the FDA is expected to continue to reward manufacturers creating

innovative new drugs with incentives, such as reduced time and money spent

in clinical trials and shorter FDA review times. While issues regarding cost

will continue, the agents approved in 2014 and those that will be approved in

2015 are important advancements in the treatment of patients across many

disease states.

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DRUG DISEASE STATE

ONCOLOGY

Beleodaq® (belinostat) Peripheral T-cell lymphoma

Blincyto® (blinatumomab) Acute lymphoblastic leukemia (ALL)

Zykadia® (ceritinib) Non–small cell lung cancer

Zydelig® (idelalisib)Chronic lymphocytic leukemia, follicular B-cell

non–Hodgkin lymphoma, and small lymphocytic lymphoma

Opdivo® (nivolumab) Melanoma

Lynparza® (olaparib) Ovarian cancer

Keytruda® (pembrolizumab) Melanoma

Cyramza® (ramucirumab)Gastric or gastroesophageal

junction adenocarcinoma

IMMUNOLOGY

Otezla® (apremilast) Psoriasis and psoriatic arthritis

Entyvio® (vedolizumab) Crohn’s disease and ulcerative colitis

RARE DISEASE

Eloctate® (antihemophilic factor [recombinant] fc fusion protein)

Hemophilia A

Obizur® (antihemophilic factor [recombinant] porcine sequence)

Hemophilia A

Table 1: 2014 specialty drug approvals1,2

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DRUG DISEASE STATE

Ruconest® (C1 esterase inhibitor [recombinant]) Hereditary angioedema

Alprolix® (coagulation factor IX [recombinant] fc fusion protein)

Hemophilia B

Cerdelga® (eliglustat) Gaucher’s disease

Vimizim® (elosulfase alfa)Mucopolysaccharidosis type IVA

(Morquio A syndrome)

Myalept® (metreleptin) Leptin deficiency

Impavido® (miltefosine) Leishmaniasis

Ofev® (nintedanib) Idiopathic pulmonary fibrosis

Esbriet® (pirfenidone) Idiopathic pulmonary fibrosis

Sylvant® (siltuximab) Multicentric Castleman’s disease

MULTIPLE SCLEROSIS

Lemtrada® (alemtuzumab) Relapsing forms of multiple sclerosis

Plegridy® (peginterferon beta-1a) Relapsing forms of multiple sclerosis

HEPATITIS C

Harvoni® (ledipasvir + sofosbuvir) Hepatitis C, genotype 1

Viekira Pak™ (ombitasvir + paritaprevir + ritonavir + dasabuvir)

Hepatitis C, genotype 1

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Table 2: Expected specialty drug approvals in Q1 and Q2 20154

EXPECTED FDA DECISION DATE

DRUG (TRADE NAME IF

AVAILABLE)

TARGET INDICATION

ROUTE

Q1 2015

IMMUNOLOGY

1/21/15* Cosentyx™ (secukinumab) Psoriasis Sub-Q

RARE DISEASE

1/23/15*Natpara®

(recombinant human parathyroid hormone)

Hypoparathyroidism Sub-Q

3/31/15 Asfotase alfa Hypophosphatasia Sub-Q

ONCOLOGY

2/3/15* Ibrance® (palbociclib) Breast cancer Oral

2/13/15* Lenvima™ (lenvatinib) Thyroid cancer Oral

3/15/15 Panobinostat Multiple myeloma Oral

* FDA approval date

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EXPECTED FDA DECISION DATE

DRUG (TRADE NAME IF

AVAILABLE)

TARGET INDICATION

ROUTE

Q2 2015

RARE DISEASE

4/13/15 Patisiran Amyloidosis IV

5/24/15 Trabectedin Soft tissue sarcoma IV

5/30/15 Sebelipase alfaLysosomal acid

lipase deficiencyIV

6/30/15 DrisapersenDuchenne muscular

dystrophySub-Q

ONCOLOGY

6/30/15 TAS-102 Colorectal cancer Oral

(does not include expanded indications for previously approved drugs)

TONY | DIPLOMAT PHARMACIST

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Highlighted Recent

Approvals

Harvoni®

Viekira Pak™

Ofev®

Esbriet®

Opdivo®

Keytruda®

14

16

18

20

22

24

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Harvoni® (ledipasvir + sofosbuvir) 4, 5 Hepatitis C

INDICATION

Treatment of adult patients with genotype 1, chronic hepatitis C infection.

CLINICAL TRIAL BRIEFING

Ledipasvir + sofosbuvir was evaluated for the treatment of patients with chronic hepatitis C, genotype 1a or 1b, with compensated liver disease in three phase 3 randomized, open-label trials composed of 1518 total patients. Patients received one tablet daily containing 90 mg of ledipasvir and 400 mg of sofosbuvir with or without ribavirin for the duration of each study. The addition of ribavirin did not increase response rates and data for patients receiving ribavirin are not included. The primary endpoint for each study was sustained virologic response (SVR) 12 weeks after the completion of dosing.

Relapse was measured as a secondary endpoint. ION-1 included treatment-naïve patients with or without cirrhosis that were given ledipasvir + sofosbuvir for 12 or 24 weeks. SVR rate was 99 percent for the 1-2 week group. Data were not available for the 2-4 week group. ION-2 included patients with or without cirrhosis who had failed a prior interferon-based treatment including regimens containing a protease inhibitor. Patients were given ledipasvir + sofosbuvir for 12 or 24 weeks. SVR rate was 94 percent after 12 weeks and 99 percent after 24 weeks. ION-3 included treatment-naïve, non-cirrhotic patients who were given ledipasvir + sofosbuvir for 8 or 12 weeks. SVR rate was 94 percent after eight weeks and 96 percent after 12 weeks.

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APPROVAL DATE: October 10, 2014MANUFACTURER: Gilead Sciences Inc.CLASS: NS5A inhibitor and nucleotide analog NS5B polymerase inhibitorSTORAGE: Room temperature below 30°C (86°F)HOW SUPPLIED: Tablets containing 90 mg of ledipasvir and 400 mg of sofosbuvir (Sovaldi®)

DOSING

Take one tablet orally once daily with or without food.

Duration of treatment: Treatment-naïve with or without cirrhosis: 12 weeks Treatment-experienced without cirrhosis: 12 weeks Treatment-experienced with cirrhosis: 24 weeks

SAFETY

Common Adverse Events: Headache and fatigue Serious Adverse Events: None

OTHER AGENTS IN THERAPEUTIC AREA

• Olysio™ (simeprevir)

• Sovaldi® (sofosbuvir)

• Viekira Pak™ (ombitasvir/paritaprevir/ritonavir/dasabuvir)

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Viekira Pak™ (ombitasvir/paritaprevir/ritonavir/dasabuvir)4, 8 Hepatitis C

INDICATION

Treatment of patients with genotype 1 chronic hepatitis C virus (HCV), including patients with compensated cirrhosis.


Ombitasvir/paritaprevir/ritonavir/dasabuvir with or without ribavirin was evaluated for the treatment of genotype 1 HCV in six randomized, multicenter clinical trials composed of 2,308 total patients. Patients on study had genotype 1a (GT1a) or 1b (GT1b) HCV. Certain trials included patients with or without cirrhosis as well as treatment-naïve or treatment-experienced patients.

Patients were dosed for 12 or 24 weeks and the primary endpoint measured for all studies was sustained virologic response (SVR) 12 weeks after the completion of therapy. SVR rates ranged from 80 percent to 100 percent across all patient populations studied. Additional studies conducted in GT1 patients who had received liver transplants demonstrated an SVR of 97 percent after 24 weeks of dosing. In patients with HCV/HCV co-infection, SVR was 91 percent in GT1a and 100 percent in GT1b after 12 or 24 weeks of dosing.

DOSING

Administer two tablets of ombitasvir/parataprevir/ritonavir once daily with food and one dasabuvir tablet twice daily with food.

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APPROVAL DATE: December 19, 2014MANUFACTURER: AbbVie Inc.CLASS: NS5A inhibitor, NS3/4A protease inhibitor, and non-nucleoside NS5B palm polymerase inhibitorSTORAGE: At or below 30°C (86°F)HOW SUPPLIED: 12.5 mg ombitasvir, 75 mg paritaprevir, and 50 mg ritonavir co-formulated in one tablet; 250 mg dasabuvir tablets; all dispensed in daily dose packages

Dosing regimen and duration of therapy for Ombitasvir/paritaprevir/ritonavir/dasabuvir:

SAFETY

Common Adverse Events: Fatigue, nausea, pruritus, other skin reactions, insomnia and asthenia in patients also taking ribavirin; Nausea, pruritus, and insomnia in patients not taking ribavirin Serious Adverse Events: ALT elevation


• Harvoni® (ledipasvir + sofosbuvir)

• Olysio® (simeprevir)

• Sovaldi® (sofosbuvir)

GENOTYPE LIVER STATUSRIBAVIRIN

CO-ADMINISTRATION

DURATION OF

THERAPY (WEEKS)

1aNon-

cirrhoticYes 12

1a Cirrhotic Yes 24

1bNon-

cirrhoticNo 12

1b Cirrhotic Yes 12

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Ofev® (nintedanib)4, 6 Rare Diseases

INDICATION

Treatment of patients with idiopathic pulmonary fibrosis (IPF).


Nintedanib was evaluated for the treatment of IPF in one phase 2 and two phase 3 randomized, double-blind, placebo-controlled studies composed of 1231 total patients. Patients were given 150 mg of nintedanib or placebo twice daily for 52 weeks. The primary endpoint for all studies was annual rate of decline in forced vital capacity (FVC). Additional secondary endpoints included time to first acute IPF exacerbation, change from baseline in FVC percent predicted, and survival.

The annual rate of decline of FVC was statistically significant in patients given nintedanib compared to placebo. Over 52 weeks, rate of decline was -60 mL for nintedanib and -191 mL for placebo in Study 1 (95 percent CI: 27, 235), -115 mL for nintedanib and -240 mL for placebo in Study 2 (95 percent CI: 78, 173), and -114 mL for nintedanib and -207 mL for placebo in Study 3 (95 percent CI: 45, 143). Time to first acute IPF exacerbation was significantly reduced in patients given nintedanib compared to placebo in Studies 1 (hazard ratio 0.16, 95 percent CI: 0.04, 0.71) and 3 (hazard ratio 0.20, 95 percent CI: 0.07, 0.56), but not in Study 2. Additionally, survival evaluation was performed in Studies 2 and 3 and did not show a statistically significant difference between nintedanib and placebo in all-cause mortality.

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APPROVAL DATE: October 15, 2014MANUFACTURER: Boehringer Ingelheim International GmbHCLASS: Kinase inhibitorSTORAGE: 25°C (77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F), protect from high humidityHOW SUPPLIED: 100 and 150 mg capsules

DOSING

150 mg orally twice daily with approximately 12 hours between doses, taken with food.

SAFETY

Common Adverse Events: Diarrhea, nausea, abdominal pain, vomiting, liver enzyme elevation, decreased appetite, headache, weight decrease and hypertension Serious Adverse Events: Elevated liver enzymes, gastrointestinal disorders, embryofetal toxicity, arterial thromboembolic events, bleeding events, and gastrointestinal perforation


• Esbriet® (pirfenidone)

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Esbriet® (pirfenidone)4, 9 Rare Diseases

INDICATION

Treatment of patients with idiopathic pulmonary fibrosis (IPF).


Pirfenidone was evaluated for the treatment of IPF in phase 3, randomized, double-blind, placebo-controlled, multicenter trials composed of 1247 patients. Patients were given 2403 mg/day of pirfenidone or placebo for 52 weeks (Study 1) or 72 weeks (Studies 2 and 3). The primary endpoint for all studies was change from baseline in percent predicted forced vital capacity (%FVC) at study completion. Additional endpoints included mean change from baseline FVC, and survival. In Studies 1 and 2, change in %FVC was statistically significant in favor of the pirfenidone groups compared to placebo, as measured at Week 52 for Study 1 and Week 72 for Study 2. Study 3 did not show a statistically significant change in %FVC as measured at Week 72. Mean treatment difference in FVC of pirfenidone compared to placebo was 193 mL (Study 1) and 157 mL (Study 2) in favor of the pirfenidone groups. Mean treatment difference was not statistically significant in Study 3. Additionally, survival evaluation was performed in all studies and did not show a statistically significant difference between pirfenidone and placebo in all-cause mortality.

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APPROVAL DATE: October 15, 2014MANUFACTURER: InterMune Inc.CLASS: PyridoneSTORAGE: 25°C (77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) HOW SUPPLIED: 267 mg capsules

DOSING

Administer orally with food.

Dosing schedule: Days 1-7: Take one capsule three times daily Days 8-14: Take two capsules three times daily Days 15 and thereafter: Take three capsules three times a day

SAFETY

Common Adverse Events: Nausea, rash, abdominal pain, upper respiratory tract infection, diarrhea, fatigue, headache, dyspepsia, dizziness, vomiting, anorexia, gastro-esophageal reflux disease, sinusitis, insomnia, weight decrease and arthralgia Serious Adverse Events: Elevated liver enzymes, photosensitivity, rash and gastrointestinal disorders


• Ofev® (nintedanib)

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Opdivo® (Nivolumab)4, 7

Oncology

INDICATION

Treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor.


Nivolumab was evaluated for the treatment of advanced melanoma in a randomized, noncomparative, multicenter, open-label clinical trial. Patients on study were previously treated with ipilimumab. During the study patients received 3 mg/kg of nivolumab every 3 weeks or investigator’s choice chemotherapy (ICC) every three weeks. ICC included options for dacarbazine or carboplatin plus paclitaxel. Treatment continued until progression or unacceptable toxicity occurred.

The primary endpoint of the study was objective response rate (ORR). At the specified time of interim analysis, ORR was achieved in 32 percent of patients given nivolumab (95 percent CI: 23, 41) after at least six months of treatment. Of the 38 patients demonstrating response, four achieved a complete response and 34 achieved a partial response. 33 patients (87 percent) showed ongoing responses ranging from 2.6+ to 10+ months. Thirteen patients had ongoing responses of six months or greater. Nivolumab was approved under the FDA Accelerated Approval program. Nivolumab continues to be evaluated in clinical trials for potential additional indications for other cancers and hematological malignancies.

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APPROVAL DATE: Decmeber 22, 2014MANUFACTURER: Bristol-Myers SquibbCLASS: Human programmed death receptor-1 (PD-1) blocking antibodySTORAGE: 2°C to 8°C (36°F to 46°F), protect from lightHOW SUPPLIED: Single use vials of 40 mg/4 mL and 100 mg/10 mL

DOSING

After dilution, administer 3 mg/kg intravenously over one hour every two weeks until disease progression or unacceptable toxicity occurs. See prescribing information for details on potential dose modifications.

SAFETY Common Adverse Events: Rash Serious Adverse Events: Immune-mediated adverse events including pneumonitis, colitis, hepatitis, nephritis, renal dysfunction, hypothyroidism and hyperthyroidism


• Tafinlar® (dabrafenib)

• Yervoy® (ipilimumab)

• Keytruda® (pembrolizumab)

• Mekinist® (trametinib)

• Zelboraf® (vemurafenib)

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Keytruda® (pembrolizumab) 4, 10 Oncology

INDICATION

Treatment of patients with unresectable or metastatic melanoma with disease progression after prior treatment with ipilimumab and, if positive for BRAF V600 mutation, a BRAF inhibitor.


Pembrolizumab was evaluated for the treatment of melanoma in a multicenter, open-label, randomized, dose-comparative Phase 1b study known as KEYNOTE-001. The study was composed of 173 patients with unresectable or metastatic melanoma with disease progression. Patients on study had received prior treatment with ipilimumab and, if BRAF mutation positive, a BRAF or MEK inhibitor. Patients received 2 mg/kg or 10 mg/kg of pembrolizumab every three weeks until disease progression or unacceptable toxicity. Tumor assessment was performed every 12 weeks.

The primary endpoints of the study were overall response rate (ORR) and duration of response (DUR). ORR was determined by Response Evaluation Criteria in Solid Tumors (RECIST) as assessed by independent blinded reviewers. In patients given 2 mg/kg of pembrolizumab, ORR was 24 percent (95 percent CI: 15, 34), one patient achieved a complete response, and 20 patients demonstrated a partial response. Duration of response ranging from 1.4+ to 8.5+ months was achieved in 86 percent of patients. ORR was similar in the 10 mg/kg group. Approval was granted under the FDA Accelerated Approval program. Additionally, pembrolizumab continues to be evaluated in clinical trials for the treatment of other

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APPROVAL DATE: September 4, 2014MANUFACTURER: Merck & Co. Inc.CLASS: Programmed death receptor-1 (PD-1) blocking antibodySTORAGE: 2°C to 8°C (36°F to 46°F)HOW SUPPLIED: Single dose vials of 50 mg for reconstitution

cancers including non-small cell lung cancer, head and neck cancers, kidney cancer, other solid tumors and hematological malignancies.

DOSING

After reconstitution, administer 2 mg/kg by intravenous infusion over 30 minutes every three weeks until disease progression or unacceptable toxicity.

SAFETY

Common Adverse Events: Fatigue, cough, nausea, pruritus, rash, decreased appetite, constipation, arthralgia and diarrhea Serious Adverse Events: Immune-mediated adverse reactions including pneumonitis, colitis, hepatitis, hypophysitis, nephritis, hyperthyroidism and hypothyroidism


• Mekinist® (trametinib)

• Proleukin® (aldesleukin)

• Tafinlar® (dabrafenib)

• Yervoy® (ipilimumab)

• Zelboraf® (vemurafenib)

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26About the Authors

RYAN CHANDANAIS, LEAD AUTHOR Ryan Chandanais is the clinical services project coordinator at

Diplomat. In his role, he spearheads pipeline drug research and

analysis. Ryan has nearly 10 years of drug development expertise,

including extensive reporting and data review experience. He

earned his Bachelor of Science in Secondary Education from

Central Michigan University and his Master of Science in Integrative

Pharmacology from Michigan State University. In 2009, Ryan became

a laboratory animal technologist through the American Association

for Laboratory Animal Science, and a certified pharmacy technician

through the Pharmacy Technician Certification Board in 2012.

RYAN NOLAN, CONTRIBUTING AUTHOR Ryan Nolan is the manager of the clinical services department for

Diplomat. In that role, he is responsible for leading a team that

provides high-quality intelligence, information resources, research and

innovative solutions to Diplomat stakeholders. Ryan has more than

six years of experience in specialty pharmacy and has overseen the

development of clinical patient care programs, adherence solutions

and a specialty-focused prior-authorization program. He graduated

from Ferris State College of Pharmacy with a doctorate in pharmacy

and from Ferris State College of Business with an MBA. In 2013,

Ryan became a certified specialty pharmacist through the Specialty

Pharmacy Certification Board. In 2014, Ryan received a Master

Certificate in Six Sigma in Healthcare from Villanova University.

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REFERENCES:1. U.S. Food and Drug Administration Center for Drug Evaluation and Research. “Novel New Drugs 2014 Summary.”

January 2015.2. CenterWatch. “FDA Approved Drugs 2014.” http://www.centerwatch.com/drug-information/fda-approved-drugs/

year/2014. Accessed January 15, 2015.3. American Association for the Study of Liver Diseases (AASLD). “Recommendations for Testing, Managing, and

Treating Hepatitis C.” Accessed January 21, 2015.4. BioPharm Insight. Boston, MA: Infinata; 2013. http://www.infinata.com/biopharma-solution/by-product/biopharm-

insight.html. Accessed January 2014.5. Harvoni® [package insert]. Foster City, CA: Gilead Sciences Inc.; 2014.6. Ofev® [package insert]. Ridgefield, CT: Boehringer Ingelheim Pharmaceuticals; 2014.7. Opdivo® [package insert]. Princeton, NJ: Bristol-Myers Squibb; 2014.

8. Viekira™ [package insert]. North Chicago, IL: AbbVie Inc.; 2014.

9. Esbriet® [package insert]. Brisbane, CA: InterMune Inc.; 2014.

10. Keytruda® [package insert]. Whitehouse Station, NJ: Merck & Co. Inc.; 2014.

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Specialty Drug Approvals-2014 Highlights + 2015 Projections

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