FDA Approves Enzalutamide Labeling Update

The FDA has approved a supplemental New Drug Application for enzalutamide to update the US product labeling for drug, which is indicated for the treatment of metastatic castration-resistant prostate cancer (mCRPC).

The approval is based on new clinical data from the TERRAIN trial showing that enzalutamide decreased the risk radiographic progression by 40% compared with bicalutamide in men with mCRPC. The median radiographic progression-free survival was 19.5 months for enzalutamide-treated patients compared with 13.4 months for bicalutamide recipients. The safety profile of enzalutamide was consistent with the findings from earlier enzalutamide trials.

The drug is marketed as Xtandi by Astellas Pharma Inc., Tokyo, and Pfizer Inc., New York. It was approved for treating mCRPC in the US in August 2012.