Zytiga Approved for Metastatic Prostate Cancer

ZYTIGA (abiraterone acetate) 250mg tablets by Centocor Ortho Biotech
ZYTIGA (abiraterone acetate) 250mg tablets by Centocor Ortho Biotech

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.