Login to Your Account

FDA OKs Prostate Cancer Drug 3 Months Ahead of PDUFA Date

By Peter Winter
BioWorld Insight Editor

Tuesday, September 4, 2012
San Francisco-based Medivation Inc. and Astellas Pharma Inc. had plenty to celebrate heading into the Labor Day holiday weekend. The FDA on Friday approved Xtandi (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel three months ahead of the product's prescription drug user fee goal date of Nov. 22.

To continue reading subscribe now to BioWorld Today

Learn More about BioWorld Today

Already a subscriber? Sign In or Buy now to activate your subscription