apalutamide


News, FDA Approval

Food and Drug Administration approved apalutamide (Erleadaâ„¢, Janssen Biotech, Inc.) 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).

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