Janssen announced that the FDA has approved Zytiga (abiraterone acetate), in combination with prednisone, for the treatment continuum for metastatic castration-resistant prostate cancer (mCRPC) before the use of chemotherapy.
Prior to this approval, Zytiga with prednisone had been approved to treat men with mCRPC who had received prior chemotherapy containing docetaxel.
The new approval is based on a supplemental New Drug Application (sNDA) that included efficacy and safety results of a Phase 3, randomized, double-blind, placebo-controlled international clinical study, which evaluated Zytiga plus prednisone vs. placebo plus prednisone in men (n=1,088) with mCRPC who had failed androgen deprivation therapy and had not received cytotoxic chemotherapy.
Zytiga, a CYP17 inhibitor, was first approved by the FDA in 2011.
For more information call (800) 457-6399 or visit www.zytiga.com.