Pharmaceutical Business review

Health Canada approves Janssen prostate cancer drug

Zytiga is indicated with prednisone for the treatment of men with metastatic prostate cancer (castration-resistant prostate cancer) who have received prior chemotherapy containing docetaxel.

The results from a Phase 3 study involving 154 Canadian men, demonstrated that at the pre-specified interim analysis, treatment with Zytiga plus prednisone resulted in a 35% reduction in the risk of death and a 3.9 month difference in median survival compared to placebo plus prednisone.

In the Phase 3 placebo-controlled, randomized, multi-center, placebo-controlled Zytiga with prednisone was investigated in patients who had received prior chemotherapy containing docetaxel.