Medivation announced that it has received written permission from the FDA to begin a pivotal Phase 3 trial of MDV3100 in patients with metastatic castration-resistant prostate cancer (CRPC) who have failed docetaxel-based chemotherapy. The placebo-controlled, double-blind, multinational trial will enroll approximately 1,200 patients who will be randomized (2:1) to receive either MDV3100 or placebo. The primary endpoint of the trial will be overall survival.

MDV3100 is a novel androgen receptor antagonist.

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