BioCentury
ARTICLE | Clinical News

Enzalutamide: Completed Phase III enrollment

June 11, 2012 7:00 AM UTC

Medivation and Astellas completed enrollment of 1,680 patients in the double-blind, placebo-controlled, international Phase III PREVAIL trial comparing once-daily 160 mg oral enzalutamide plus standard of care (SOC) vs. SOC alone. Last month, Medivation submitted an NDA to FDA for enzalutamide to treat castration-resistant prostate cancer (CRPC) in patients previously treated with docetaxel. The company requested Priority Review. The product has Fast Track designation in the U.S. to treat advanced prostate cancer in post-chemotherapy patients. ...