BioCentury
ARTICLE | Clinical News

Zytiga abiraterone acetate regulatory update

November 19, 2012 8:00 AM UTC

EMA's CHMP issued a positive opinion to expand the label of Zytiga abiraterone from Johnson & Johnson to include treatment in combination with prednisone or prednisolone of chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC) who are asymptomatic or mildly asymptomatic after failing androgen deprivation therapy. The recommendation includes a new contraindication of severe hepatic impairment. Zytiga is also under Priority Review in the U.S. for the indication. J&J submitted the application in mid-June. A 6-month Priority Review would place the PDUFA date in mid-December; the company would not disclose a specific date (see BioCentury, June 18). ...