Pharmaceutical Business review

Janssen-Cilag prostate cancer drug gets EC approval

The results from a placebo-controlled, randomised, multicenter Phase 3 study treatment with abiraterone acetate in conjunction with prednisone or prednisolone resulted in a 35.4% reduction in the risk of death and an improvement of 3.9 months in median overall survival, compared to placebo and prednisone or prednisolone.

In the trial, the patients were randomized 2:1 to receive abiraterone acetate 1,000mg daily plus prednisone or prednisolone 5mg twice daily or placebo in combination with prednisone or prednisolone 5 mg twice daily (control arm).