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FDA Agrees to Review Supplemental NDA for Enzalutamide in Metastatic Prostate Cancer

Tony Berberabe, MPH @OncBiz_Wiz
Published: Tuesday, Feb 23, 2016

The FDA has accepted, for review, a supplemental new drug application (sNDA) for enzalutamide (Xtandi) capsules in patients with metastatic castration-resistant prostate cancer (mCRPC) that includes findings from the head-to-head studies, TERRAIN and STRIVE. The sNDA updates the section of the label that discusses the clinical studies. Astellas Pharma, Inc reports that no change in indication is being sought. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is October 22, 2016.
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