Wes Chapman's Blog

240% Growth in Oncology Drug Approvals in 2017

Good News for Cancer Patients

Wes Chapman

January 2, 2018

Introduction

Advances in medical oncology depend on successful drug development – and that means successful clinical trials, leading to approval by the FDA for compounds that materially extend and improve the lives of cancer patients. 2017 was a banner year for approval of drug applications in oncology with 48 approvals in total, 16 for new drugs. The recent success in clinical trials is critical to cancer patients, and in this blog I take a look at what these approvals were, what they mean to cancer patients today, and where they point in the future.

The Environment for Drug Development

Patient access to advances in cancer care medicines is controlled by the Food and Drug Administration (FDA), which must approve new drug applications by pharmaceutical companies before new drugs can be marketed. This approval process is expensive, times consuming, and designed to ensure that only safe and efficacious medications are sold to cancer patients. In almost every case, the process is conducted in a large real-world experiment called a clinical trial. Clinical trials are carefully designed and conducted to prove the safety and efficacy of a new drug, starting in animals and finally culminating in controlled use in humans.

Clinical trials typically start with a compound in the lab, and move into a series of carefully structured trials, ultimately leading to new therapies in clinical practice – for about 5.4% of drugs that start the process. In summary, the process to approval typically is:

• Phase Zero; these are lab and animal model data exercises to show the potential viability of a drug.
• Phase I; phase I trials are human trials in a small number of participants, designed to test for dosing toxicity. Increasingly, phase I trials are showing early stage efficacy.
• Phase II; phase II trials are larger trials, to provide early data on safety and efficacy, and to inform future trial design.
• Phase III; phase III trials are scaled to provide the needed data to prove safety and efficacy for approval.

The FDA recognized the critical need for patients to have access to effective therapies at the earliest possible opportunity, and created a number of mechanisms for patients to get access to drugs sooner than the traditional approval process allowed. The tools available to get more rapid patient access include:

• Accelerated approval, created in 1992, regulations that allow drugs for serious conditions that filled an unmet medical need to be approved based on a surrogate endpoint.
• Breakthrough therapy; created in 2012, a process designed to expedite the development and review of drugs which may demonstrate substantial improvement over available therapy.
• Fast track; created in 1997, a process designed to facilitate the development, and expedite the review of drugs to treat serious conditions and fill an unmet medical need.
• Priority Review; created in 2007, designation means FDA’s goal is to take action on an application within 6 months.

Finally, as oncology drug development has increasingly focused on specific genetic disorders, more of these drugs are focused on a small number of patients. Accordingly, these drugs are also frequently accorded Orphan Drug Status by the FDA, which provides certain tax credits for their clinical development and other commercial advantages.

The legislative creation of these new expedited programs began with the passage of legislation for Orphan Drugs in 1983, and culminated with the creation of Breakthrough status in 2012. One of the results of this shift to expedited programs has been the increased importance of phase II clinical trials in expedited approval. A good example of this early approval through expedited programs is Kymriah, a (CAR) T-cell therapy, approved 8/30/2017. The approval was granted for phase II trial, for pediatric acute lymphoblastic leukemia (ALL), based on 63 patients. The drug had an overall remission rate of 82.5%, for patients who had failed other therapy, and was granted Breakthrough and Orphan status.

The analysis in this report is designed to look at factors relevant to patients in the evaluation and review of the last two years of clinical trials. Cancer patients face a number of extraordinarily difficult choices, including whether to participate in a clinical trial. Understanding the environment and recent history for trials may help put that decision into context. The analysis in this report is largely based on information from the FDA websites, Hematology/Oncology (Cancer) Approvals & Safety Notifications and ClinicalTrials.gov. An additional partial bibliography is provided.

FDA Cancer Approvals 2017 & 2016 – Analysis

2017 saw the highest level of new cancer drug approvals in 21 years (48) versus just 20 the prior year, 2016. The rate and nature of approvals reflects major changes in the nature of drugs approved for use in cancer care. Cancer care is undergoing a major change, with a rush of new and effective therapies available for patients. These include immune based oncology (I/O) therapies, and the fascinating subset called chimeric antigen receptor for T cells (CAR) T-cell, which have collectively radically improved the potential outcomes for certain patients – but presented new and previously unknown side effects, as well as jaw-dropping costs.

These drugs are made available to cancer patients after the drugs are approved by the FDA for marketing to patients. Because the ability to market is based on trials focused on a very specific cancer type or location (lung, skin, etc.) pharmaceutical companies are required to conduct trials to demonstrate safety and efficacy on each new clinical application, called label changes. In most years, there are many more trials related to label changes than new compounds. As an example, in 2017 16 drugs (33.3% of the total) were first time approvals. This was up from only one drug (5% of the total) in 2016.

Oncology Drug Approvals in 2016 and 2017

Type of oncology drug	2017		2016
		% Total		% Total
New Drug	16	33.3%	1	5%
Existing Drug	32	66.7%	19	95%
Total	48	100%	20	100%
FDA reporting included 7 non-oncology related drug applications and 2 diagnostic tests in 2017; and 1 non-oncology drug and 1 diagnostic test in 2016. These have been excluded in this analysis. 2017 does include 2 bio-similar drugs.

 

Looking from an historical perspective, in the 12 year period from 1990 to 2002, only 71 applications were approved, versus 68 in the last 2 years alone. Of the 51 approvals for existing drugs in the last two years, 28 are multiple approvals for the 9 drugs listed in the table below. Typically these are label extensions or combination trials for recently approved compounds. The two most frequent are Opdivo (Bristol Meyers Squibb) and Keytruda (Merck) with 7 approvals each.

 

2017 & 2016 Multiple Approvals

Drug	Year first approved	Drug type	Applicant Identifier	2017 Approval	2016 Approval	Total
Nivolumab	2014	Check Point inhibitor	OPDIVO, Bristol-Myers Squibb	4	3	7
Cabozantinib	2011	Small molecule inhibitor of the tyrosine kinases c-Met	Cabometyx, Exelixis, Inc	2	0	2
Obinutuzumab	2013	humanized anti-CD20 monoclonal antibody	Gazyva Injection, Genentech, Inc	1	1	2
Pembrolizumab	2014	Check Point inhibitor	KEYTRUDA, Merck & Co	5	2	7
Avelumab	2017	Fully human monoclonal antibody	BAVENCIO, EMD Serono	2	0	2
Palbociclib	2015	Selective inhibitor of the cyclin-dependent kinases CDK4 and CDK6	IBRANCE, Pfizer Inc	1	1	2
Lenalidomide	2004	Derivative of thalidomide introduced in 2004 – Chemo	Revlimid, Celgene Corp	1	1	2
Atezolizumab	2016	Check Point inhibitor	TECENTRIQ, Genentech Oncology	0	2	2
Erlotinib	2015	receptor tyrosine kinase inhibitor, (EGFR)	TARCEVA, Astellas Pharm Global	0	2	2
				16	12	28

 

There are 4 additional evaluation criteria that may be helpful for patients in understanding the current clinical trials environment:

• Use Accelerated Approval; Accelerated approval was used in about a third of the trials for granting preliminary FDA approval in both 2017 and 2016 (33.3% and 35.0% respectively). This is an important trend for patients, as it is opening up beneficial drugs earlier than waiting for the completion of the phase III trial for a given compound.
• Use of other Expedited Programs; Expedited programs have become the norm in clinical trials for cancer. These programs accounted for 81.3% of approvals in 2017, and 75.0% in 2016. Use of these programs facilitates the early approval of promising compounds, but ultimately requires completion of full efficacy and safety testing. Participating in early trials with expedited approval is now an important opportunity for patients considering treatment options.
• Phase I or II trials; Early phase trials have become an important source of approval, accounting for 43.8% and 35.0% of approvals in 2017 and 2016 respectively.
• Combination drug trials; Combination trials accounted for 9 approvals in 2017, up from 5 in 2016. Combination drug therapy is a staple of cancer care, and combination drug trials are an important investigational area from which patients can benefit.

 

Evaluation Criteria	2017		2016
		% Total		% Total
Accelerated Approval	16	33.3%	7	35.0%
Other Expedited Program	39	81.3%	19	75.0%
Phase I or II	21	43.8%	7	35.0%
Combination Drug Trial	9	18.8%	5	25.0%

 

One of the most confusing issues related to oncology drugs in general, and clinical trials in particular is the issue of endpoints for the determination of efficacy. As noted by Johnson et al., in End Points and United States Food and Drug Administration Approval of Oncology Drugs, “Guidance promulgated in the 1980’s indicated that efficacy should be demonstrated by prolongation of life, a better life, or an established surrogate for at least one of these.”

The approvals granted in the last two years used at least (I only counted the primary efficacy endpoint) 13 different efficacy measures to approve a total of 68 drugs. I understand why this is difficult. The mechanisms of action are very different in most of these compounds, and they function on very specific bio-chemical pathways.

Somehow, I think that input from patients should be incorporated into efficacy endpoints. While I recognize that patients may have very different value preferences for efficacy, understanding how these differ in patient populations may benefit trial design. Furthermore, understanding the actual efficacy benefit may be important to patients in shared decision making in normal clinical care.

In the chart below, I look at the high and low ranges of the 13 effectiveness measures utilized in the approvals in 2017 and 2016. Four of the measures were utilized in only one approval, and the greatest range noted was in complete response rate – from 1.4% to 96.1%; a factor of 68.6x. Clearly, expected value to the patient is vastly greater at 96.1% complete response rate, despite the clinical validity for both outcomes.

 

Effectiveness Definitions 2017, 2016
Measure	Lowest Reported Value	Highest Reported Value
Invasive Disease Free Survival Advantage (IDFS)	1.6%	2.3%
Progression Free Survival Advantage Months (PFS)	3.3	18.0
Molecular response Advantage	10.3%	10.3%
Disease Free Survival Advantage (Years)	1.2	1.2
Event Free Survival (Months)	7.8	7.8
Complete Remission + Incomplete Remission Advantage %	15.6%	22.0%
Reduction of risk of disease progression	61%	61%
Overall Survival Advantage (months)	1.3	11.8*
Objective Response Rate	10.0%	81.0%
Overall Response Rate	33.0%	80.0%
Complete response rate	1.4%	96.1%
Recurrence Free Survival Advantage (RFS)	11.5	11.5
Overall Response Rate Advantage %	16.0%	36.0%
* Data not yet calculated for 2 trials

 

 

 

 

 

2017 Drug Approvals

 

Date	Drug	Applicant	Approval Type	Expediated Program	Indication	Number of Patients	Prior approval	Phase
12/20/2017	Pertuzumab	PERJETA, Genentech, Inc	Regular	Priority review	For use in combination with trastuzumab and chemotherapy as adjuvant treatment of patients with HER2-positive early breast cancer.	4804	2012	III
12/20/2017	Nivolumab	OPDIVO, Bristol-Myers Squibb	Regular	Priority review, Breakthrough Therapy	For the adjuvant treatment of patients with melanoma	906	2014	III
12/19/2017	Bosutinib	BOSULIF, Pfizer Inc.	Accelerated	Priority Review and Orphan Drug	Treatment of patients with newly-diagnosed chronic phase (CP) Philadelphia chromosome positive (Ph+) chronic myelogenous leukemia (CML).	487	2012	III
12/19/2017	Cabometyx	Cabometyx, Exelixis, Inc.	Regular	Priority Review	Treatment of patients with advanced renal cell carcinoma (RCC)	157	2016	II
12/1/2017	Ogivri	Trastuzumab-dkst, Mylan	Biosimilar	Regular	Treatment of patients with HER2-overexpressing breast or metastatic stomach cancer	NA	None	BioSim
11/16/2017	Sunitinib malate	Sutent, Pfizer Inc.	Regular	None	The adjuvant treatment of adult renal cell carcinoma following nephrectomy.	615	2006	III
11/16/2017	Obinutuzumab	GAZYVA, Genentech, Inc	Regular	Priority Review	In combination with chemotherapy, followed by obinutuzumab monotherapy in patients achieving at least a partial remission, for the treatment of adult patients with previously untreated stage II bulky, III, or IV follicular lymphoma (FL)	1202	2013	III
11/9/2017	Dasatinib	SPRYCEL, Bristol-Myers Squibb Co	Regular	Priority Review,  Orphan Product	The treatment of pediatric patients with Philadelphia chromosome-positive (Ph+) chronic myeloid leukemia (CML) in the chronic phase.	97	2006	I & II
11/9/2017	Brentuximab Vedotin	ADCETRIS, Seattle Genetics, Inc.	Regular	Breakthrough Therapy Designation, Orphan Designation, and priority review	The treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy.	131	2011	III
11/6/2017	Alectinib	ALECENSA, Hoffmann-La Roche, Inc./Genentech, Inc	Accelerated	Breakthrough therapy designation	For treatment of patients with anaplastic lymphoma kinase (ALK)-positive metastatic non-small cell lung cancer (NSCLC)	303	2015	III
11/6/2017	Vemurafenib	ZELBORAF, Hoffmann-La Roche Inc	Regular	Priority review. Breakthrough Therapy and Orphan Drug	For the treatment of patients with Erdheim-Chester Disease (ECD) with BRAF V600 mutation.	22	2012	II
10/31/2017	Acalabrutinib	Calquence, AstraZeneca Pharmaceuticals Inc.	Accelerated	Breakthrough Therapy, Orphan Drug designation, and priority review	For treatment of adult patients with mantle cell lymphoma (MCL) who have received at least one prior therapy.	124	None	II
10/18/2017	Axicabtagene ciloleucel	YESCARTA, Kite Pharma, Inc.)	Regular	Orphan drug designation, priority review and Breakthrough Therapy	Adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy.	108	None	II
9/28/2017	Abemaciclib	VERZENIO, Eli Lilly and Company	Regular	Priority review and Breakthrough Therapy	For women with HR-positive, HER2-negative advanced or metastatic breast cancer with disease progression following endocrine therapy.	669	None	III
9/22/2017	Nivolumab	OPDIVO, Bristol-Myers Squibb Co.	Accelerated	Priority review	For the treatment of hepatocellular carcinoma (HCC) in patients who have been previously treated with sorafenib.	154	2014	II
9/22/2017	Pembrolizumab	KEYTRUDA, Merck & Co., Inc	Accelerated	Priority review	For patients with recurrent locally advanced or metastatic, gastric or gastroesophageal junction adenocarcinoma whose tumors express PD-L1	259	2014	II
9/14/2017	Cabazitaxel	JEVTANA, Sanofi-Aventis	Regular	None	For the treatment of patients with metastatic castration-resistant prostate cancer previously treated with a docetaxel-containing treatment regimen.	1200	2010	Post Market
9/14/2017	Copanlisib	ALIQOPA, Bayer HealthCare Pharmaceuticals Inc	Accelerated	FDA previously granted orphan drug and fast track	The treatment of adult patients with relapsed follicular lymphoma who have received at least two prior systemic therapies.	104	None	II
9/14/2017	Mvasi	Bevacizumab-awwb, Amgen Inc	Biosimilar	None	U.S. Food and Drug Administration approved Mvasi (bevacizumab-awwb, Amgen Inc.) as a biosimilar to Avastin (bevacizumab, Genentech Inc.).	NA	None	BioSim
9/1/2017	Gemtuzumab ozogamicin	Mylotarg, Pfizer Inc	Regular	FDA previously granted orphan drug designation to gemtuzumab ozogamicin	The treatment of newly-diagnosed CD33-positive acute myeloid leukemia (AML) in adults	294	2000	III & II
8/30/2017	Tisagenlecleucel	KYMRIAH, Novartis Pharmaceuticals Corp	Regular	FDA approved tisagenlecleucel with a Risk Evaluation and Mitigation Strategy. Breakthrough therapy designation	For the treatment of patients up to age 25 years with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or in second or later relapse.	63	None	II
8/17/2017	Olaparib	Lynparza, AstraZeneca	Regular	Fast Track status	Maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy.	560	2014	III
8/17/2017	Inotuzumab ozogamicin	BESPONSA, Wyeth Pharmaceuticals Inc	Regular	Orphan Drug and Breakthrough Therapy, priority review.	The treatment of adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL).	326	None	III
8/3/2017	liposome-encapsulated combination of daunorubicin and cytarabine	VYXEOS, Jazz Pharmaceuticals	Regular	Breakthrough Therapy and Orphan Drug, priority review.	The treatment of adults with newly-diagnosed therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), two types of AML having a poor prognosis.	309	Both underlying drugs	III
8/2/2017	Ibrutinib	Imbruvica, Pharmacyclics LLC	Regular	Breakthrough Therapy and Orphan Drug, priority review.	The treatment of adult patients with chronic graft versus host disease (cGVHD) after failure of one or more lines of systemic therapy.	42	2013	III
8/1/2017	Enasidenib	IDHIFA, Celgene Corp	Regular	Orphan Drug and Fast Track, as well as priority review.	The treatment of adult patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase-2 (IDH2) mutation as detected by an FDA-approved test.	199	None	I,II
8/1/2017	Nivolumab	OPDIVO, Bristol-Myers Squibb Company	Accelerated	Priority review	The treatment of patients 12 years and older with mismatch repair deficient (dMMR) and microsatellite instability high (MSI-H) metastatic colorectal cancer that has progressed following treatment with a fluoropyrimidine, oxaliplatin, and irinotecan.	53	2014	II
7/17/2017	Neratinib	NERLYNX, Puma Biotechnology, Inc	Regular	None	For the extended adjuvant treatment of adult patients with early stage HER2-overexpressed/amplified breast cancer, to follow adjuvant trastuzumab-based therapy.	2840	None	III
7/11/2017	Blinatumomab	BLINCYTO, Amgen Inc	Regular	Follow up study	The treatment of relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL) in adults and children.	405	2014	III
6/22/2017	Dabrafenib and trametinib	TAFINLAR and MEKINIST, Novartis Pharmaceuticals Inc	Regular	Breakthrough Therapy Designation in 2015	For patients with metastatic non-small cell lung cancer (NSCLC) with BRAF V600E mutation as detected by an FDA-approved test.	93	2014, 2015	II
6/22/2017	Rituximab and hyaluronidase	RITUXAN HYCELA, Genentech Inc	Regular	None	For adult patients with follicular lymphoma, diffuse large B-cell lymphoma, and chronic lymphocytic leukemia.	NA	2006	NA
5/26/2017	ceritinib	ZYKADIA, Novartis Pharmaceuticals Corp	Regular	None	For patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are anaplastic lymphoma kinase (ALK)-positive as detected by an FDA-approved test.	376	2014	III
5/23/2017	Pembrolizumab	KEYTRUDA, Merck & Co	Accelerated	priority review status and accelerated approval	Unresectable or metastatic, microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) solid tumors that have progressed following prior treatment and who have no satisfactory alternative treatment options or with MSI-H or dMMR colorectal cancer that has progressed following treatment.	149	2014	III
5/18/2017	Pembrolizumab	KEYTRUDA, Merck & Co	Accelerated	priority review status	For patients with locally advanced or metastatic urothelial carcinoma who are not eligible for cisplatin-containing chemotherapy	370	2014	II
5/10/2017	Pembrolizumab	KEYTRUDA, Merck & Co	Accelerated	priority review status	In combination with pemetrexed and carboplatin for the treatment of patients with previously untreated metastatic non-squamous non-small cell lung cancer (NSCLC)	123	2014	I & II
5/9/2017	Avelumab	BAVENCIO, EMD Serono, Inc	Accelerated	priority review status	For patients with locally advanced or metastatic urothelial carcinoma whose disease progressed during or following platinum-containing chemotherapy or within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.	242	None	II?
5/1/2017	Durvalumab	IMFINZI, AstraZeneca UK	Accelerated	Breakthrough Therapy, Orphan Drug, priority review status	For the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy or who have disease progression within 12 months of neoadjuvant or adjuvant treatment with platinum-containing chemotherapy.	182	None	II?
4/28/2017	Brigatinib	ALUNBRIG tablets, Takeda Pharmaceutical	Accelerated	priority review status	For the treatment of patients with metastatic anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib.	222	2016	II
4/28/2-17	Midostaurin	RYDAPT, Novartis Pharmaceuticals Corp	Regular	Breakthrough Therapy, Fast track, priority review status	Adult acute myeloid leukemia in combination with standard cytarabine and daunorubicin induction and cytarabine consolidation.	717	None	III
4/27/2017	Regorafenib	STIVARGA, Bayer HealthCare Pharmaceuticals Inc	Regular	Priority review and Orphan Drug	Hepatocellular carcinoma (HCC)	573	2015	III
3/31/2017	Palbociclib	IBRANCE, Pfizer Inc	Regular	Priority Review and Breakthrough Therapy Designation	The treatment of (HER2) negative advanced or metastatic breast cancer in combination with an aromatase inhibitor as initial endocrine based therapy in postmenopausal women.	666	2015	III
3/30/2017	Osimertinib	TAGRISSO, AstraZeneca Pharmaceuticals	Regular	Fast Track and Breakthrough Therapy Designation, Orphan Drug	(EGFR) mutation-positive non-small cell lung cancer (NSCLC)	419	2015	III
3/27/2017	Niraparib	ZEJULA, Tesaro, Inc	Regular	Fast Track, Priority Review and Breakthrough Therapy designation, as well as Orphan Drug	For the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete or partial response to platinum-based chemotherapy.	553	None	III
3/23/2017	Avelumab	BAVENCIO, EMD Serono, Inc	Accelerated	Orphan drug status and breakthrough therapy designation, and priority review.	For the treatment of patients 12 years and older with metastatic Merkel cell carcinoma (MCC).	200	None	II
3/15/2017	KEYTRUDA	(KEYTRUDA), Merck and Co., Inc	Accelerated	Orphan Drug Designation for the treatment of HL, and Breakthrough Therapy Designation for the current indication. priority review	For the treatment of adult and pediatric patients with refractory classical Hodgkin lymphoma (cHL), or those who have relapsed after three or more prior lines of therapy.	210	2014	II
3/13/2017	Ribociclib	KISQALI, Novartis Pharmaceuticals	Regular	priority review and breakthrough therapy	For the treatment of postmenopausal women with (HER2)-negative advanced or metastatic breast cancer.	668	None	III
2/22/2017	Lenalidomide	Revlimid, Celgene Corp	Regular	None	As maintenance therapy for patients with multiple myeloma following autologous stem cell transplant.	517	2006	III
2/22/2017	Nivolumab	OPDIVO, Bristol-Myers Squibb	Accelerated	Breakthrough therapy designation and priority review	Locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy.	270	2014	II

 

 

 

 

 

 

 

 

 

2016 Drug Approvals

Date	Drug	Applicant	Approval Type	Special Designation	Indication	Number of Patients	Prior Approval	Phase
12/19/2016	Rucaparib	RUBRACA, Clovis Oncology, Inc	Accelerated	Breakthrough therapy designation, priority review status, and orphan drug designation.	For treatment of patients BRCA mutation (germline and/or somatic); advanced ovarian cancer who have been treated with two or more chemotherapies.	106	None	II
11/21/2016	Daratumumab	DARZALEX, Janssen Biotech	Regular	Breakthrough therapy and orphan drug designation, as well as priority review	Combination with lenalidomide; dexamethasone, bortezomib and dexamethasone, for the treatment of patients with multiple myeloma, at least one prior therapy.	569	2013	III
11/10/2016	Nivolumab	OPDIVO Injection, Bristol-Myers Squibb	Regular	None	For the treatment of patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) with disease progression on or after a platinum-based therapy.	361	2015	III
10/24/2016	Pembrolizumab	KEYTRUDA, Merck & Co., Inc.	Regular	Breakthrough therapy designation and priority review	For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors express PD-L1.	305, 1033	2014	II&III
10/19/2016	Olaratumab	LARTRUVO, Eli Lilly and Company	Accelerated	Fast track and breakthrough therapy designation, priority review status	For the treatment of patients with soft tissue sarcoma (STS) not amenable to radiotherapy or surgery.	133	21015 Europe	II
10/18/2016	Atezolizumab	TECENTRIQ, Genentech Oncology	Regular	None	For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose disease progressed during or following platinum-containing chemotherapy	1137	2016	III
10/18/2016	Erlotinib	TARCEVA, Astellas Pharm	Regular	None	Modified the indication for erlotinib (TARCEVA, Astellas Pharm Global Development Inc.) for treatment of non-small cell lung cancer (NSCLC) to limit use to patients whose tumors have specific epidermal growth factor receptor (EGFR) mutations.	643	2015	III
9/13/2016	Nivolumab	Opdivo, Bristol-Myers Squibb	Dosing modification	None	The approval modifies the Dosage and Administration section of nivolumab (3 mg/kg intravenously every two weeks) with the new recommended regimen of 240 mg IV every two weeks.	NA	2015	NA
8/5/2016	Pembrolizumab	KEYTRUDA injection, Merck Sharp & Dohme Corp	Accelerated	Priority Review.	For the treatment of patients with recurrent or metastatic head and neck squamous cell carcinoma (HNSCC) with disease progression on or after platinum-containing chemotherapy.	174	2014	NA
5/18/2016	Atezolizumab	Tecentriq, Genentech, Inc	Accelerated	Breakthrough Therapy Designation, priority review status.	For the treatment of patients with locally advanced or metastatic urothelial carcinoma who have disease progression during or following platinum-containing chemotherapy.	310	None	II
5/17/2016	Nivolumab	(Opdivo, marketed by Bristol-Myers Squibb)	Accelerated	Breakthrough Therapy Designation, priority review status.	For the treatment of patients with classical Hodgkin lymphoma (cHL) that has relapsed or progressed after autologous hematopoietic stem cell transplantation (HSCT) and post-transplantation brentuximab vedotin (Adcetris).	95 efficacy, 263 safety	2015	II
5/13/2016	Lenvatinib capsules	Lenvima, Eisai, Inc	Accelerated	Breakthrough Therapy Designation, priority review status.	For the treatment of advanced renal cell carcinoma following one prior anti-angiogenic therapy. The combination of lenvatinib plus everolimus demonstrated numerically superior PFS, objective response rate, and overall survival.	153	2015	II
4/25/2016	Cabozantinib	CABOMETYX, Exelixis, Inc	Regular	Breakthrough Therapy Designation, Fast Track, and Priority Review.	For the treatment of advanced renal cell carcinoma in patients who have received prior anti-angiogenic therapy.	658	2011	III
4/11/2016	Venetoclax	VENCLEXTA  tablets, AbbVie, Inc	Accelerated	Orphan drug status for the treatment of CLL and was granted Breakthrough Therapy Designation. Priority Review	For the treatment of patients with chronic lymphocytic leukemia (CLL) with 17p deletion, as detected by an FDA-approved test, who have received at least one prior therapy.	106	2015	II
3/11/2016	Crizotinib capsules	Xalkori, Pfizer, Inc	Regular	Priority Review, Breakthrough Therapy Designation	For the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumors are ROS1-positive.	50	2011	II
2/26/2016	Everolimus	Afinitor , Novartis	Regular	None	For the treatment of adult patients with progressive, well-differentiated non-functional, neuroendocrine tumors (NET) of gastrointestinal (GI) or lung origin with unresectable, locally advanced or metastatic disease.	302	2009	III
2/26/2016	Obinutuzumab	Gazyva Injection, Genentech, Inc	Regular	Priority Review	For use in combination with bendamustine followed by obinutuzumab monotherapy for the treatment of patients with follicular lymphoma (FL) who relapsed after, or are refractory to, a rituximab-containing regimen.	321	2013	III
2/19/2016	Palbociclib	IBRANCE Capsules, Pfizer, Inc	Regular	Priority Review and Breakthrough Therapy Designation	Palbociclib (IBRANCE Capsules, Pfizer, Inc.) in combination with fulvestrant for the treatment of women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer with disease progression.	521	2015	III
1/28/2016	Eribulin	HALAVEN® injection, Eisai Co.,	Regular	Priority Review.	HALAVEN injection, Eisai Co., Ltd. for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.	446	2010	III
1/19/2016	Ofatumumab	Arzerra Injection, Novartis Pharmaceuticals	Regular	Priority Review.	For extended treatment of patients who are in complete or partial response after at least two lines of therapy for recurrent or progressive chronic lymphocytic leukemia (CLL).	474	2009	III