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news.Janssen-Cilag has received marketing authorization for Zytiga (abiraterone acetate) from the European Commission as a treatment for metastatic castration-resistant prostate cancer (mCRPC).
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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).