Astellas, Medivation submit European Marketing Authorization Application for XTANDI capsules

Apr 4 2014NewsGuard 100/100 Score

Astellas Pharma Inc. (TSE:4503) and Medivation Inc. (NASDAQ: MDVN) today announced the submission of a variation to amend the European Marketing Authorization Application for XTANDI® (enzalutamide) capsules for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy and in whom chemotherapy is not yet clinically indicated. XTANDI is currently approved in Europe for the treatment of adult men with mCRPC whose disease has progressed on or after docetaxel chemotherapy.

The European application is based on the results from the Phase 3 PREVAIL trial evaluating XTANDI as compared to placebo in more than 1,700 chemotherapy-naive mCRPC patients.

SOURCE Astellas Pharma US, Inc.

Posted in: Men's Health News | Drug Trial News

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