FDA Approves New Indication for Enzalutamide

The FDA has approved a new indication for the use of enzalutamide (Xtandi) in men with metastatic castration-resistant prostate cancer (mCPRC).

The drug, which is an androgen receptor inhibitor taken orally once daily, initially was approved in August 2012 for use in patients with mCRPC who previously received chemotherapy with docetaxel. With the new indication, the drug is approved for use in men with mCRPC who have not previously received chemotherapy.

In the phase 3 PREVAIL trial, patients receiving enzalutamide and gonadotropin-releasing hormone (GnRH) therapy experienced a significant 29% reduction in the risk of death and an 83% decrease in the risk of radiographic progression or death compared with patients who received placebo plus GnRH therapy. Enzalutamide also delayed time to initiation of chemotherapy and time to a skeletal-related event.

The drug is jointly marketed by Astellas Pharma Inc., of Tokyo, and Medivation, Inc., of San Francisco.

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