Drug for Late-Stage Prostate Cancer Approved
The FDA has approved enzalutamide to treatment men with metastatic castration-resistant prostate cancer (CRPC).
The drug, co-marketed under the brand name Xtandi by Astellas Pharma U.S., Inc., of Northbrook, Ill., and Medivation, Inc., of San Francisco, is approved for patients previously treated with docetaxel. Enzalutamide was reviewed under the FDA's priority review program.
Enzalutamide's safety and effectiveness was evaluated in a study of 1,199 patients with metastatic CRPC who had received prior treatment with docetaxel. The median overall survival was 18.4 months for men who received the drug compared with 13.6 months for patients who received placebo.
The most common adverse effects observed in study participants taking enzalutamide included weakness or fatigue, back pain, diarrhea, joint pain, hot flush, tissue swelling, musculoskeletal pain, headache, upper respiratory infections, and dizziness. Seizures occurred in approximately 1% of those receiving enzalutamide.