The Food and Drug Administration (FDA) has approved a label update for Zytiga (abiraterone acetate; Janssen Biotech) to include statistically significant results in combination with prednisone for the treatment of chemotherapy-naive men with metastatic castration-resistant prostate cancer (mCRPC). The study data have been recently published in The Lancet Oncology.

The FDA label approval was based on the final analysis of the COU-AA-302 study, a Phase 3, randomized, double-blind, placebo-controlled study. Data showed that Zytiga plus prednisone significantly prolonged median overall survival (OS) vs. placebo plus prednisone in chemotherapy-naive men with mCRPC. Patients in the Zytiga plus prednisone group demonstrated a median OS of 34.7 months vs. 30.3 months for patients in the placebo plus prednisone arm (HR 0.81, 95% CI: 0.70–0.93; P<0.0033) after a median follow-up of more than four years.

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Zytiga is a CYP17 inhibitor that was initially approved in 2011 with prednisone for the treatment of men with mCRPC who have received prior chemotherapy containing docetaxel. In 2012, Zytiga was approved for the treatment continuum for mCRPC before the use of chemotherapy.

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