Priority Review Granted for Zytiga for Metastatic Castration-Resistant Prostate Cancer Before Chemotherapy
Janssen Research & Development announced that the FDA has granted Priority Review to the supplemental New Drug Application (sNDA) for Zytiga (abiraterone acetate) administered in combination with prednisone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy.
The Zytiga sNDA submission is based on the efficacy and safety results of an international Phase 3, randomized, double-blind, placebo-controlled clinical study that evaluated Zytiga plus prednisone compared to placebo plus prednisone in 1,088 asymptomatic or mildly symptomatic men with mCRPC who had not received chemotherapy.
Zytiga in combination with prednisone was approved by the FDA in April 2011 for the treatment of patients with mCRPC who have received prior chemotherapy containing docetaxel.
For more information call (800) 457-6399 or visit www.zytiga.com.