FDA accepts for review supplemental NDA for XTANDI® (enzalutamide) Capsules
formulation approved dose, tolerability and immunologic efficacy, investigational new formulation Astellas Pharma Inc. and Medivation, Inc. announced that the U.S. Food and Drug Administration (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 2 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.
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The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is October 22, 2016.
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A Type-II variation to update the Summary of Product Characteristics (SmPC) has also been submitted to the European Medicines Agency.