Abiraterone Approved to Treat Metastatic Prostate Cancer

The FDA approved abiraterone (Zytiga) to treat metastatic, castration-resistant prostate cancer before chemotherapy, the agency announced.

Abiraterone, which decreases testosterone production, was previously approved to treat men with prostate cancer that progressed after they took the chemotherapy drug docetaxel.

In a trial released online in the New England Journal of Medicine, over 1000 men with metastatic, castration-resistant prostate cancer who were naive to chemotherapy were randomized to abiraterone or placebo. All were given prednisone. Patients taking abiraterone had longer radiographic progression-free survival than did those taking placebo (16.5 vs. 8.3 months).

Some of the common side effects included fatigue, joint swelling, fluid retention, hot flush, diarrhea, vomiting, and high blood pressure.