Centocor Ortho Biotech announced that the FDA has approved Zytiga (abiraterone acetate), an oral, once-daily medication for use in combination with prednisone for the treatment of men with metastatic castration-resistant prostate cancer who have received prior chemotherapy containing docetaxel. This approval was based on results from a Phase 3, randomized, placebo-controlled, multicenter study that showed that at pre-specified interim analysis, treatment with Zytiga in combination with prednisone resulted in a 35% reduction in the risk of death (14.8 months vs. 10.9 months; hazard ratio (HR) = 0.646 [0.543–0.768]; P<0.0001) and a 3.9 month difference in median survival compared to placebo plus prednisone. In an updated analysis, results were consistent with those from the interim analysis with a 4.6 month difference between the two arms in median survival (15.8 months vs. 11.2 months [HR = 0.74]).
Abiraterone acetate is converted in vivo to abiraterone, an androgen biosynthesis inhibitor, that inhibits 17 α-hydroxylase/C17,20-lyase (CYP17). This enzyme is expressed in testicular, adrenal, and prostatic tumor tissues and is required for androgen biosynthesis.
For more information call (800) 457-6399 or visit www.centocororthobiotech.com.