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.”


FDA Grants Bevacizumab Priority Review for Recurrent Platinum-Resistant Ovarian Cancer

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 drug Avastin (bevacizumab), already FDA-approved for several subtypes of several different cancers, was recently granted Priority Review status for the treatment of women with recurrent platinum-resistant ovarian cancer. The decision was based on promising results for the treatment in a clinical trial with volunteer patients.

“The U.S. Food and Drug Administration (FDA) has accepted Genentech’s supplemental Biologics License Application and granted Priority Review for bevacizumab (Avastin) plus chemotherapy for the treatment of women with recurrent platinum-resistant ovarian cancer.

“ ‘The majority of women with ovarian cancer will become resistant to platinum therapy, and a quarter of women will have platinum-resistant disease at the time of a first recurrence. New treatment options are needed,’ said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development.

“The designation of Priority Review status is granted to medicines that the FDA believes have the potential to provide ‘significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of serious conditions when compared to standard applications.’ The supplemental Biologics License Application for bevacizumab plus chemotherapy for recurrent platinum-resistant ovarian cancer is based on data from the phase III AURELIA trial.”


FDA Grants Merck’s Anti-PD1 Antibody Priority Review

“The FDA has granted Merck’s anti-PD1 antibody MK-3475 a priority review designation for the treatment of unresectable or metastatic melanoma in patients who have previously been treated with ipilimumab. Priority review status is reserved for drugs considered to offer a significant improvement in the safety or efficacy of the treatment of a serious condition. It will shorten the drug’s FDA review period from 10 months to 6 months.”

Editor’s note: MK-3475 is an immunotherapy drug that works by boosting a patient’s own immune system to fight cancer. While this story is about melanoma, anti-PD1 drugs like MK-3475 have also shown promise for other cancers. Once it is approved by the FDA for unresectable or metastatic melanoma, doctors in the U.S. will be able to prescribe it to their patients outside of the clinical trial system. 


FDA Grants Merck’s Anti-PD1 Antibody Priority Review

“The FDA has granted Merck’s anti-PD1 antibody MK-3475 a priority review designation for the treatment of unresectable or metastatic melanoma in patients who have previously been treated with ipilimumab. Priority review status is reserved for drugs considered to offer a significant improvement in the safety or efficacy of the treatment of a serious condition. It will shorten the drug’s FDA review period from 10 months to 6 months.”

Editor’s note: MK-3475 is an immunotherapy drug that works by boosting a patient’s own immune system to fight cancer. Once it is approved by the FDA for unresectable or metastatic melanoma, doctors in the U.S. will be able to prescribe it to their patients outside of the clinical trial system.


FDA Grants Merck’s Anti-PD1 Antibody Priority Review

“The FDA has granted Merck’s anti-PD1 antibody MK-3475 a priority review designation for the treatment of unresectable or metastatic melanoma in patients who have previously been treated with ipilimumab. Priority review status is reserved for drugs considered to offer a significant improvement in the safety or efficacy of the treatment of a serious condition. It will shorten the drug’s FDA review period from 10 months to 6 months.”

Editor’s note: MK-3475 is an immunotherapy drug that works by boosting a patient’s own immune system to fight cancer. While this story is about melanoma, anti-PD1 drugs like MK-3475 have also shown promise for other cancers, including for lung cancer. Once it is approved by the FDA for unresectable or metastatic melanoma, doctors in the U.S. will be able to prescribe it to their patients outside of the clinical trial system. 


FDA Grants Priority Review to Xtandi for Advanced Prostate Cancer

“The FDA today granted priority review to enzalutamide for the treatment of chemotherapy-naive patients with metastatic castration-resistant prostate cancer, according to a press release issued by the drug’s manufacturers.

“The FDA based its decision in part on results of the phase 3 PREVAIL trial, which included more than 1,700 patients with chemotherapy-naive disease who progressed during treatment with a luteinizing hormone-releasing hormone analogue or after bilateral orchiectomy.”

Editor’s note: Enzalutamide (Xtandi) is a promising treatment for prostate cancer that has been shown to benefit patients in clinical trials. Based on this promise, the U.S. Food and Drug Administration (FDA) will review the drug and decide whether to allow oncologists across the U.S. prescribe it to people with metastatic castration-resistant prostate cancer who have not been treated with chemotherapy. The FDA is expected to make a decision by September 18.