The United States Food and Drug Association has approved the use of enzalutamide for patients with metastatic castration-resistant prostate cancer (CRPC).  

Enzalutamide is an androgen receptor inhibitor that is taken orally once a day.

It was initially approved in August 2012 for use in patients with metastatic CRPC who had previously received chemotherapy; the new indication approves enzalutamide for use in patients who have not received chemotherapy.

Researchers hope that this will make the drug more useful and accessible for a wider variety of patients.

"This enables the use of an important therapy by patients with metastatic castration-resistant prostate cancer at all stages of their disease," said Dr Sef Kurstjens, chief medical officer of Astellas Pharma Inc. and president of Astellas Pharma Global Development, Inc.

In a Phase 3 PREVAIL trial, men receiving enzalutamide in combination with gonadotropin-releasing hormone therapy (GnRH) exhibited a statistically significant improvement in both overall survival and delayed time to radiographic progression or death, as compared to those on placebo and GnRH therapy.

Enzalutamide significantly reduced the risk of radiographic progression or death by 83% compared with placebo.

"In this setting, [enzalutamide] has been shown to extend overall survival and significantly delay the progression of prostate cancer," said Dr Tomasz M. Beer, co-principal investigator of the PREVAIL study, deputy director of the Knight Cancer Institute and professor of medicine at Oregon Health & Science University.

"The result is a meaningful period of time during which men have their disease controlled without the need for chemotherapy."

Source: Medivation