FDA Approves Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer

FDA Approves Enzalutamide for Nonmetastatic Castration-Resistant Prostate Cancer

The US Food and Drug Administration (FDA) approved enzalutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC) as well as metastatic CRPC.1

This latest approval now makes enzalutamide the only FDA-approved oral medication indicated for both metastatic and nonmetastatic CRPC.

The FDA based its approval on results from the PROSPER phase 3 trial (ClinicalTrials.gov Identifier: NCT02003924), for which researchers randomly assigned 1401 men with nonmetastatic CRPC to receive enzalutamide plus androgen deprivation therapy (ADT) or placebo plus ADT.
Results showed that the median metastasis-free survival (MFS) was 36.6 months among men assigned to the enzalutamide arm compared with 14.7 months in the ADT alone arm (hazard ratio [HR], 0.29; 95% CI, 0.24-0.35; P