240% Growth in Oncology Drug Approvals in 2017; Good News for Cancer Patients

240% Growth in Oncology Drug Approvals in 2017; Good News for Cancer Patients

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
Wes Chapman
Written by Wes Chapman

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