Medication Monitor

Generic Name (Trade Name—Company)
May 1, 2011


(Zytiga—Centocor Ortho Biotech)
Treatment of metastatic castration-resistant prostate cancer


Treatment of patients with metastatic castration-resistant prostate cancer who have already received prior chemotherapy with docetaxel; abiraterone should be used in combination with prednisone

Abiraterone is a once-daily, oral androgen biosynthesis inhibitor. It is unique from other androgen deprivation therapies because abiraterone blocks androgen production from three sources (testicular, adrenal, and prostate tumor tissues) compared with only one source (testicular) for other treatments. FDA relied on data from a pivotal Phase III trial involving 1,195 patients with metastatic advanced prostate cancer previously treated with docetaxel showed that patients given abiraterone 1,000 mg once daily plus prednisone/prednisolone 5 mg twice daily had a 35% reduction in the risk of death compared with those given placebo plus corticosteroids. Some of the most common adverse events reported during this trial in patients treated with abiraterone were joint swelling or discomfort (29.5%) and edema (26.7%).