Astellas, Medivation Granted Priority Review From FDA For XTANDI Capsules

(RTTNews) - Medivation Inc. (MDVN) and Astellas Pharma Inc. (ALPMY, ALPMY) reported the U.S. Food and Drug Administration or FDA's acceptance for filing the supplemental New Drug Application or sNDA to extend the indication for XTANDI capsules for the treatment of men with metastatic castration-resistant prostate cancer or mCRPC, who haven't received chemotherapy. The sNDA application was granted Priority Review designation with a stated FDA Prescription Drug User Fee Act review date of September 18, 2014.

Currently, XTANDI is approved to treat patients with mCRPC who have earlier received docetaxel chemotherapy.

The sNDA application is based on the Phase 3 PREVAIL trial results, assessing XTANDI compared with placebo in over 1,700 chemotherapy-naïve mCRPC patients. The FDA's acceptance of the sNDA triggers a milestone payment to Medivation under its collaboration agreement with Astellas.