Xtandi amendment submitted to EU for mCR Prostate Cancer - Astellas/Medivation

Astellas Pharma and Medivation have 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 III PREVAIL trial evaluating Xtandi as compared to placebo in more than 1,700 chemotherapy-naive mCRPC patients. The co-primary endpoints of the trial were overall survival and radiographic progression-free survival. The trial was designed to evaluate enzalutamide at a dose of 160 mg taken orally once daily versus placebo.