Xtandi and deliver: US FDA OK's Medivation/Astellas mCRPC drug in record time
This article was originally published in Scrip
Barely a month after the US FDA accepted Medivation's and Astellas Pharma's application to market Xtandi (enzalutamide/MDV3100) as a treatment for men with metastatic castration-resistant prostate cancer (mCRPC) previously treated with docetaxel-based chemotherapy and granted a six-month priority review, the agency, in unusual lightening speed, gave the medicine its blessing on 31 August – well ahead of the 22 November action date, catching all of Wall Street off guard.
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