The FDA has granted priority review to the supplemental New Drug Application for Zytiga (abiraterone, Janssen Biotech) given in combination with prednisone for patients with metastatic castration-resistant prostate cancer who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy. Under the Prescription Drug User Fee Act, the agency will aim to conclude its review within six months-i.e., by the end of the year.
The submission is based on the efficacy and safety results of an international Phase III, randomized, double-blind, placebo-controlled study reported at this year's ASCO Annual Meeting evaluating Zytiga plus prednisone vs. placebo plus prednisone in asymptomatic or mildly symptomatic men with metastatic castrate-resistant prostate cancer who had not received chemotherapy.