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Urology: Castration-Resistant Prostate Cancer Drug Approved

by Erin Moore

The U.S. Food and Drug Administration (FDA) has approved abiraterone acetate (Zytiga), a new oral medication for men with late-stage prostate cancer. Abiraterone is indicated in combination with prednisone for metastatic disease in patients who have received docetaxel therapy.

Abiraterone decreases the production of cytochrome P450 17A1, a protein which stimulates testosterone and sometimes cancer. Approval was based on improved survival in a clinical study of 1,195 patients with late-stage, castration-resistant prostate cancer. When men who had exhausted many of their other options took abiraterone once daily along with twice-daily prednisone, they lived for about four months longer than men taking a placebo-prednisone combination.

The most common side effects included joint swelling and discomfort, low potassium levels, fluid retention, hot flashes, and diarrhea. Abiraterone is marketed by Centocor Ortho Biotech, Inc., Horsham, PA.

Source: Food and Drug Administration. 2011. FDA approves Zytiga for late-stage prostate cancer. Published on April 28, 2011 on the FDA website.