FDA Approves Zytiga for Prostate Cancer

Article date: May 2, 2011

The US Food and Drug Administration has approved the drug Zytiga (abiraterone acetate) for some men with advanced prostate cancer who have already been treated with chemotherapy.

In a large clinical trial, the drug helped such men live about 4 months longer.

Zytiga works by lowering testosterone, a hormone that fuels prostate cancer growth. It is a pill that men take along with the steroid prednisone.

The combination is approved for men with late-stage prostate cancer that is still growing, despite previous treatment to lower testosterone levels. This type of prostate cancer is called “castration resistant.” There are few treatment options for it, so the FDA approved Zytiga on an accelerated 6-month schedule.

Common side effects of Zytiga include joint swelling or discomfort, low levels of potassium in the blood, fluid retention, and hot flashes. Men in the study also reported urinary problems (including urinary tract infections), high blood pressure, upset stomach, and diarrhea. Severe side effects were rare in the study.

The drug is marketed by Centocor Ortho Biotech.