Janssen Research & Development, LLC, announced today that the U.S. Food and Drug Administration (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 FDA grants Priority Review to medicines that may offer major advances in treatment, or provide a treatment option where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA will aim to conclude its review within six months of the sNDA submission. The sNDA was submitted in June.
"We believe that men with mCRPC whose disease is asymptomatic or mildly symptomatic, for whom chemotherapy may not be immediately necessary, have limited treatment options and that this disease setting represents a critical unmet medical need," said Michael L. Meyers, M.D., Ph.D., Vice President, Compound Development Team Leader, ZYTIGA. "We are delighted the FDA has granted a Priority Review designation for our sNDA."
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. Data from this study were presented at the 48th Annual Meeting of the American Society of Clinical Oncology (ASCO) in June.
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.
Janssen Research & Development, LLC