U.S. FDA Approves New Indication for the Use of XTANDI® (enzalutamide) Capsules for Patients with Metastatic Castration-Resistant Prostate Cancer

SAN FRANCISCO and TOKYO, September 11, 2014 /PRNewswire/ --

Approval based on improved overall survival, delayed time to radiographic progression and an overall positive benefit-risk profile    

Medivation, Inc. (Nasdaq: MDVN) and Astellas Pharma Inc. (Tokyo: 4503) have announced that the U.S. Food and Drug Administration (FDA) has approved a new indication for the use of XTANDI^® (enzalutamide) capsules to treat patients with metastatic castration-resistant prostate cancer (CRPC). This new approved use follows a priority review of the supplemental New Drug Application (sNDA) that was based on results of the Phase 3 PREVAIL trial.

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The FDA initially approved XTANDI, an oral, once-daily androgen receptor inhibitor, in August 2012 for use in patients with metastatic CRPC who previously received docetaxel (chemotherapy). The new indication approves XTANDI for use in men with metastatic CRPC who have not received chemotherapy. Metastatic CRPC is defined as a cancer that has spread beyond the prostate gland and has progressed despite treatment to lower testosterone (i.e., with a gonadotropin-releasing hormone (GnRH) therapy or with removal of the testes).  

"The FDA's priority review and approval of this new indication for XTANDI now enables the use of an important therapy by patients with metastatic castration-resistant prostate cancer at all stages of their disease," said Sef Kurstjens, M.D., Ph.D., chief medical officer of Astellas Pharma Inc. and president of Astellas Pharma Global Development, Inc.  "We are pleased that these patients now have XTANDI available as a treatment option."

"All of us at Medivation extend our thanks to the clinicians and patients who participated in the PREVAIL clinical trial culminating in today's approval," said David Hung, M.D., founder, president and chief executive officer, Medivation, Inc. "As a company dedicated to the rapid development of novel therapies to treat serious diseases, we are pleased to see XTANDI approved in this important patient population."

In the Phase 3 PREVAIL trial, men receiving XTANDI and GnRH therapy exhibited a statistically significant improvement in both overall survival and delayed time to radiographic progression or death as compared to those on placebo and GnRH therapy.    

• XTANDI significantly reduced the risk of radiographic progression or death by 83% compared with placebo (HR=0.17; p < 0.0001).
• XTANDI significantly reduced the risk of death by 29% compared with placebo (HR=0.71; p < 0.0001).