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ARTICLE | Company News

FDA approves Zytiga label expansion

December 11, 2012 2:12 AM UTC

FDA approved an sNDA to expand the label for Zytiga abiraterone from Johnson & Johnson (NYSE:JNJ) to include use in combination with prednisone to treat chemotherapy-naïve patients with metastatic castration-resistant prostate cancer (CRPC). In November, EMA's CHMP issued a positive opinion recommending expanding Zytiga's label to include use in combination with prednisone or prednisolone of chemotherapy-naïve patients with metastatic CRPC who are asymptomatic or mildly asymptomatic after failing androgen deprivation therapy. J&J said the U.S. label for Zytiga does not include language restricting the use of Zytiga to patients who are asymptomatic or mildly asymptomatic.

Zytiga is already approved in the U.S. and EU in combination with prednisone to treat metastatic CRPC patients who have received prior chemotherapy containing docetaxel. J&J gained the inhibitor of steroidal enzyme 17 alpha-hydroxylase/C17, 20 lyase ( CYP17) through its 2009 acquisition of Cougar Biotechnology Inc. The pharma reported nine-month worldwide revenues for Zytiga of $697 million. ...