FDA Approves Apalutamide for Nonmetastatic Castration-Resistant Prostate Cancer

On February 14, 2018, the U.S. Food and Drug Administration (FDA) approved apalutamide (Erleada) for patients with non-metastatic castration-resistant prostate cancer (NM-CRPC). Approval was based on a multicenter, double-blind, clinical trial (SPARTAN, NCT01946204) randomizing 1,207 patients with NM-CRPC (2:1) to receive either apalutamide, 240 mg orally once daily in combination with ADT (medical castration or surgical castration) (n=806), or placebo once daily with ADT (n=401).