SNDA filed with FDA for Xtandi (enzalutamide) in prostate cancer - Astellas and Medivation
Astellas Pharma and Medivation have announced that the FDA has accepted for review a supplemental New Drug Application (sNDA) that they have submitted for Xtandi (enzalutamide) capsules in metastatic castration-resistant prostate cancer (mCRPC), which includes findings from the Phase II TERRAIN and STRIVE studies, to update the relevant clinical sections within the current indication.
Enzalutamide is approved by the FDA for the treatment of patients with mCRPC. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is October 22, 2016.
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