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.