FDA approves label update for Zytiga (abiraterone acetate) plus prednisone, in Prostate Cancer- Janssen Biotech

The FDA has approved a label update for Zytiga (abiraterone acetate) plus prednisone, from Janssen Biotech, based on the final analysis of the Phase III, randomized, double-blind, placebo-controlled COU-AA-302 study, which showed that Zytiga plus prednisone significantly prolonged median overall survival (OS), compared to placebo plus prednisone, in chemotherapy-naive men with metastatic castration-resistant prostate cancer (mCRPC).

After a median follow-up of more than four years (49.2 months), the Janssen-sponsored registration study demonstrated a median OS of almost three years (34.7 months) in the patients randomized to Zytiga plus prednisone compared to 30.3 months in the placebo plus prednisone arm (median OS, 34.7 vs. 30.3 months). The final analysis data was recently published in the February 2015 issue of The Lancet Oncology with an independent commentary. Additionally, Janssen presented these data at the European Society for Medical Oncology (ESMO) 2014 Congress. Based on the results from the final analysis, Janssen is working with relevant global health authorities to revise the label for ZYTIGA to include the final analysis results.

See: "Abiraterone acetate plus prednisone versus placebo plus prednisone in chemotherapy-naive men with metastatic castration-resistant prostate cancer (COU-AA-302): final overall survival analysis of a randomised, double-blind, placebo-controlled phase 3 study." Ryan CJ, Smith MR, Fizazi K, et al. Lancet Oncol. 2015;16(2):152-160.