Medivation and Astellas announced that the FDA has approved Xtandi (enzalutamide) capsules for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC) who have previously received docetaxel (Taxotere; Sanofi Aventis).

The efficacy and safety of Xtandi were assessed in a randomized, placebo-controlled, multicenter Phase 3 clinical trial. A total of 1,199 patients with mCRPC who had previously received docetaxel were randomized 2:1 to receive either Xtandi orally at a dose of 160mg once daily (N=800) or placebo (N=399). The primary endpoint of the trial was overall survival. Xtandi-treated patients had a statistically-significant improvement in median overall survival compared to the placebo group: 18.4 months in the Xtandi group vs. 13.6 months in the placebo group (P<0.0001). Xtandi provided a 37% reduction in risk of death compared to placebo (hazard ratio=0.631).

Enzalutamide is an androgen receptor inhibitor that acts on different steps in the androgen receptor signaling pathway. Medivation and Astellas expect to make Xtandi available in mid-September 2012.

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This article originally appeared on MPR