publication date: Apr. 30, 2015

FDA Updates Zytiga Label To Include Chemotherapy-Naive Metastatic CRPC Data


FDA approved a label update for Zytiga (abiraterone acetate) plus prednisone to include overall survival results in chemotherapy-naive men with metastatic castration-resistant prostate cancer.

The update was 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, compared to placebo plus prednisone.

After a median follow-up of more than four years (49.2 months), the Janssen Research & Development-sponsored registration study demonstrated a median OS of 34.7 months in the patients randomized to Zytiga plus prednisone compared to 30.3 months in the placebo plus prednisone arm (HR= 0.81 [95% CI, 0.70-0.93]; p=0.0033).

Overall survival is particularly meaningful in this final analysis because 65 percent of men in the ZYTIGA plus prednisone arm and 78 percent in the placebo plus prednisone arm received subsequent therapy that may prolong OS in mCRPC. This includes 44 percent of men in the control arm who subsequently received Zytiga plus prednisone. Additionally, with a median of 49 months of follow-up, there were no notable changes in the safety profile of Zytiga since the previously reported interim analyses.

The final analysis data was recently published in the February 2015 issue of The Lancet Oncology with an independent commentary. Additionally, Janssen first presented these data at the European Society for Medical Oncology Congress in Madrid in September 2014. Based on the results from the final analysis, Janssen is … Continue reading CCL April – FDA Updates Zytiga Label To Include Chemotherapy-Naive Metastatic CRPC Data

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