The FDA granted expedited approval for enzalutamide (Xtandi; Medivation and Astellas Pharma US) on August 31, 2012. Enzalutamide was approved for the treatment of patients with metastatic castration-resistant prostate cancer (CRPC) who have previously received docetaxel.
Approval was based on the results of a single randomized, placebo-controlled, multicenter trial of 1199 patients with metastatic CRPC. The study was designed to measure overall survival in men receiving enzalutamide compared with men receiving a placebo. The median overall survival for those patients who received enzalutamide was 18.4 months, compared with 13.6 months for those who received placebo.
For more information about enzalutamide, please click here.
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