FDA Grants Alectinib Priority Review in NSCLC

“Alectinib has received an FDA priority review designation for patients with ALK-positive, locally advanced or metastatic non–small cell lung cancer (NSCLC) who have progressed or are intolerant to crizotinib (Xalkori), according to Genentech, the manufacturer of the oral second-generation ALK inhibitor. The FDA’s action date for an approval decision is March 4, 2016.

“The priority review is based on two phase II trials (NP286731and NP287612) which demonstrated that alectinib had robust activity in patients with ALK-positive NSCLC following progression on crizotinib (Xalkori), including individuals with CNS metastases.

“ ‘Alectinib was granted priority review by the FDA based on results from two studies showing the medicine shrank tumors in people with ALK-positive NSCLC that progressed on crizotinib,’ Sandra Horning, MD, chief medical officer and head of Global Product Development at Genentech, said in a statement. ‘There is a need for new treatment options in this patient population, especially because the disease often spreads to the brain at progression.’ “


FDA Grants Nivolumab Priority Review in Nonsquamous NSCLC

“Nivolumab (Opdivo) has received an FDA priority review designation for patients with previously treated nonsquamous non­–small cell lung cancer (NSCLC), according to the developer of the PD-1 inhibitor, Bristol-Myers Squibb (BMS). Under the expedited process, the FDA’s decision deadline is January 2, 2016.

“The FDA simultaneously granted nivolumab a breakthrough therapy designation in this setting. The priority and breakthrough designations are based on data from the phase III CheckMate-057 trial, in which second-line nivolumab reduced the risk of death by 27% versus docetaxel in patients with nonsquamous NSCLC, including a 60% risk reduction among patients with the highest levels of PD-L1 expression.

“Nivolumab was previously approved in March 2015 for patients with squamous cell NSCLC who have progressed on or after platinum-based chemotherapy.”


Pembrolizumab Promised Fast FDA Action on Frontline Melanoma Indication

“Pembrolizumab (Keytruda) has received priority review from the US Food and Drug Administration (FDA) as frontline treatment for patients with advanced melanoma, according to Merck, the manufacturer of the anti–PD-1 checkpoint inhibitor. A final decision is expected from the FDA by December 19, 2015.

“In a separate action, the FDA delayed its decision date on an application for pembrolizumab in ipilimumab-refractory advanced melanoma to December 24, 2015, based on the need to review additional data submitted by Merck.

“ ‘Through our clinical program for KEYTRUDA we have accumulated substantial data on the role of our anti–PD-1 therapy in advanced melanoma. We look forward to the FDA’s review of each of these applications, and to delivering on our goal of helping patients with advanced melanoma to achieve long-term disease control and survival,’ said Roger M. Perlmutter, MD, PhD, president, Merck Research Laboratories.”


FDA Grants Priority Review to Keytruda for Advanced NSCLC

“The FDA accepted for review the supplemental biologics license application of pembrolizumab for advanced non–small cell lung cancer, according to a press release from the drug’s manufacturer.

“Further, the FDA granted priority review and breakthrough therapy designation to pembrolizumab (Keytruda, Merck) — a humanized monoclonal antibody that blocks the interaction between programmed cell death-1 (PD-1) and its ligands, PD-L1 and PD-L2 — for advanced NSCLC with a target action date of October 2, 2015.

“The FDA will review the use of pembrolizumab in patients with advanced NSCLC whose disease has progressed on or after platinum chemotherapy and an FDA-approved therapy for epidermal growth factor receptor or ALK genomic tumor aberrations, if present.”


FDA Grants Priority Review of Opdivo as the First Treatment Option in Metastatic Melanoma

“Bristol-Myers Squibb Company BMY, -0.35% today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the supplemental Biologics License Application (sBLA) for Opdivo(nivolumab)for the treatment of previously untreated patients with unresectable or metastatic melanoma. The FDA also granted Priority Review for this application. The projected FDA action date is August 27, 2015.

“Opdivo was first approved by the FDA in December 2014 for patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. This initial indication was approved under accelerated approval based on tumor response rate and durability of response from CheckMate -037 clinical trial results. This new sBLA accepted by the FDA includes data from CheckMate -066, which evaluated Opdivo in treatment naïve patients with BRAF wild-type advanced melanoma as compared to dacarbazine chemotherapy (DTIC). In the trial, safety and tolerability were well-characterized with fewer treatment-related Grade 3/4 adverse events observed with Opdivo than dacarbazine.

“ ‘The CheckMate -066 trial marked the first time that a PD-1 immune checkpoint inhibitor showed a survival benefit in a randomized Phase III trial,’ said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. ‘We look forward to continuing to work with the FDA to ensure cancer patients are provided the latest clinical advances that have the potential for improved responses and long-term survival.’ “


U.S. Food and Drug Administration Accepts Biologics Licensing Application for Opdivo (Nivolumab) for the Treatment of Advanced Squamous Non-Small Cell Lung Cancer

“Bristol-Myers Squibb Company today announced that the U.S. Food and Drug Administration (FDA) has accepted for filing and review the Biologics Licensing Application (BLA) for Opdivo (nivolumab)for the treatment of patients with advanced squamous non-small cell lung cancer (NSCLC) after prior therapy. The FDA also granted Priority Review for this application. The Prescription Drug User Fee Act (PDUFA) goal date for a decision is June 22, 2015.

“In the U.S., lung cancer is one of the leading causes of cancer deaths. Non-small cell lung cancer, one of the most common types accounting for approximately 85 percent of cases, includes three main subtypes including squamous NSCLC. Squamous NSCLC accounts for approximately 25 to 30 percent of all lung cancers.

“ ‘With the acceptance of our application for Opdivo in the squamous non-small cell lung cancer setting, Bristol-Myers Squibb marks another significant milestone in its goal to deliver a new treatment option for this challenging to treat patient population,’ said Michael Giordano, MD, senior vice president, Head of Oncology Development, Bristol-Myers Squibb. ‘As a company that prides itself in helping patients prevail over deadly diseases, we are proud of this achievement and look forward to making Opdivo available to the lung cancer community.’ ”


FDA Has Not Yet Planned Meeting to Evaluate Palbociclib for Postmenopausal Women with Advanced ER+ HER2- Breast Cancer

The gist: In October, the U.S. Food and Drug Administration (FDA) announced that it had granted Priority Review to new breast cancer drug palbociclib, meaning that it would speed its review process to get the drug to more patients sooner. However, as of January 2015, the FDA has not yet planned a meeting to evaluate the drug. The reason for the delay has not been announced. Palbociclib has shown promise for postmenopausal women with advanced, ER-positive, HER2-negative breast cancer. If it is approved by the FDA, doctors across the U.S. will be able to prescribe palbociclib to these patients.

“The U.S. Food and Drug Administration isn’t planning an advisory committee meeting at this time to evaluate Pfizer Inc.’s experimental breast-cancer treatment, despite the drug having received priority-review status in October, the company said Thursday.

“Pfizer didn’t provide reasons for the delay, but said it continues to talk with the FDA about the application for palbociclib, also known by the brand name Ibrance.

“An FDA spokesperson wasn’t immediately available to respond.

“The drug is one of many experimental therapies that targets certain proteins in the body known as CDKs. Cancer hijacks these proteins to help tumor cells grow. Recent studies suggest that stopping these proteins can help stall cancer.”


Pfizer Announces FDA Acceptance of Palbociclib New Drug Application with Priority Review

The gist: In the U.S., a drug must be approved by the U.S. Food and Drug Administration (FDA) in order for it to be prescribed to patients with specific diseases. Particularly promising drugs might be granted Priority Review, meaning that the FDA agrees to work with the drug manufacturer to accelerate the approval process. The FDA recently granted priority review to a drug meant to treat certain breast cancer patients. The drug is called palbociclib. It is meant to be combined with another drug called letrozole as a treatment for “postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease.”  The FDA’s decision was based on promising results for the treatment in a clinical trial that tested it in volunteer patients. People who are interested in getting the treatment before it is approved can look into participating in Pfizer’s expanded access trial.

“Pfizer Inc. today announced the New Drug Application (NDA) for palbociclib has been accepted for filing and granted Priority Review by the United States Food and Drug Administration (FDA). This NDA requests FDA approval of palbociclib, in combination with letrozole, as a first-line treatment for postmenopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not received previous systemic treatment for their advanced disease. The submission is based on the final results of PALOMA-1, a randomized, Phase 2 trial comparing palbociclib plus letrozole versus letrozole alone in this population of patients.

“The FDA’s Priority Review status accelerates the review time from 10 months to a goal of six months from the day of acceptance of filing and is given to drugs that may offer major advances in treatment or may provide a treatment where no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is April 13, 2015.

“Palbociclib received Breakthrough Therapy designation from the FDA in April 2013, for the first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer.

“ ‘If approved as a first-line therapy in combination with letrozole, palbociclib will be an important new option for the thousands of women in the U.S. who are living with metastatic breast cancer,’ said Garry Nicholson, president, Pfizer Oncology. ‘We look forward to continuing to work closely with the FDA through the review process.’

“Pfizer recently announced the initiation of a multi-center, open-label expanded access program (EAP) in the United States for palbociclib. Through the program, palbociclib is available to post-menopausal women with hormone receptor-positive (HR+), HER2- advanced breast cancer who are eligible for letrozole therapy and for whom enrolling in other palbociclib clinical trials is not an option. Healthcare professionals and patients can learn more about the palbociclib EAP by visiting www.clinicaltrials.gov (trial number: NCT02142868).”


FDA Grants Priority Review to Lanreotide Injection for Gastroenteropancreatic Neuroendocrine Tumors

Editor’s note: In the U.S., a drug must be approved by the U.S. Food and Drug Administration (FDA) in order for it to be prescribed to patients with specific diseases. Particularly promising drugs might be granted Priority Review, meaning that the FDA agrees to work with the drug manufacturer to accelerate the approval process. The FDA recently granted priority review to a drug meant to treat a subset of pancreatic cancer tumors known as gastroenteropancreatic neuroendocrine tumors. The drug is called lanreotide (aka Somatuline Depot). The FDA’s decision was based on promising results for the lanreotide in a clinical trial that tested it in volunteer patients.

“The U.S. Food and Drug Administration (FDA) has accepted and granted priority review to Ipsen’s supplemental New Drug Application (sNDA) for the somatostatin analog lanreotide (Somatuline Depot) 120 mg injection in the treatment of gastroenteropancreatic neuroendocrine tumors. The FDA designates priority review status to drug candidates that have the potential to offer a significant improvement in treatment compared to currently approved options. A decision is expected in early 2015.

“In the United States, lanreotide is indicated for the long-term treatment of patients with acromegaly who have had an inadequate response to or cannot be treated with surgery and/or radiotherapy. The active substance in the drug is lanreotide acetate, a somatostatin analog that inhibits the secretion of several endocrine, exocrine, and paracrine amines and peptides.

“ ‘[Lanreotide] is the first and only somatostatin analog to demonstrate a statistically significant improvement in progression-free survival in patients with gastroenteropancreatic neuroendocrine tumors in a large, multinational clinical trial,’ said Cynthia Schwalm, President and CEO of Ipsen North America.”