Phase III enzalutamide data published in NEJM

Results from the phase III PREVAIL trial of the oral androgen receptor inhibitor enzalutamide (XTANDI) have been published online in the New England Journal of Medicine (June 1, 2014).

The trial, one of the main talking points from the recently concluded 2014 AUA annual meeting in Orlando, FL, found that enzalutamide added to androgen deprivation therapy at the time of progression provides meaningful clinical benefit to men with chemotherapy-naïve metastatic castrate-resistant prostate cancer.

"The PREVAIL study results demonstrate that treatment with enzalutamide in men with metastatic castration-resistant prostate cancer can decrease the risk of death, delay the growth or spread of metastatic prostate cancer, and delay the time to initiation of chemotherapy. We are delighted that the New England Journal of Medicine has chosen to publish these important results,” said co-principal investigator Tomasz M. Beer, MD, of the Knight Cancer Institute at Oregon Health & Science University, Portland.

Based on the results of the trial, Astellas Pharma Inc. and Medivation filed a supplemental new drug application to extend the indication for enzalutamide capsules for the treatment of men with mCRPC who have not received chemotherapy. The FDA has accepted the application and granted it priority review designation, with an FDA Prescription Drug User Fee Act review date of Sept. 18, 2014, according to a joint Astellas-Medivation press release.

Dr. Beer has a scientific study/trial relationship with Astellas Pharma and Medivation, and several of his PREVAIL co-authors are consultants/advisers for and/or have another relationship with Astellas Pharma and/or Medivation.

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