FDA Approves <em>Zytiga</em> In Earlier Prostate Cancer Setting

FDA Approves Zytiga In Earlier Prostate Cancer Setting

11 Dec 2012

• By Michael Goodman

FDA approval of Zytiga in the pre-chemo setting gives the androgen blocker a second prostate cancer indication and another revenue stream – but a short remaining patent life and a significant competitive threat may mitigate the achievement.

FDA’s approval of Janssen Biotech Inc.’s Zytiga (abiraterone acetate) for use in men with metastatic castration-resistant prostate cancer with mild or no symptoms who have not been treated with chemotherapy is a sign that a clear drug effect need not be weighed down by statistical concerns.

Janssen R&D LLC reported in March 2012 that the Cougar-302 trial on which Zytiga was approved for the chemo-naïve...