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Astellas Pharma and Medivation receive priority review from FDA for XTANDI capsules in chemotherapy-naive advanced prostate cancer

Tuesday, 6 May 2014 07:00am EDT 

Astellas Pharma Inc and Medivation Inc:Says that the U.S. Food and Drug Administration (FDA) has accepted for filing the supplemental New Drug Application (sNDA) to extend the indication for XTANDI capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.This sNDA application was granted Priority Review designation with a stated FDA Prescription Drug User Fee Act (PDUFA) review date of Sept. 18, 2014.XTANDI is approved for the treatment of patients with mCRPC who have previously received docetaxel chemotherapy.SNDA application is based on the results from the Phase 3 PREVAIL trial evaluating XTANDI as compared to placebo in more than 1,700 chemotherapy-na├»ve mCRPC patients. 

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3 Jul 2015