FDA New Drug and Biologic Approvals, 2018 Midyear Review

Mary L Windle, PharmD


August 01, 2018

In This Article

Prostate Cancer: Erleada (apalutamide)

Indication: Nonmetastatic, castration-resistant prostate cancer (NM-CRPC).

Mechanism: Androgen receptor (AR) inhibitor that binds directly to the ligand-binding domain of the AR. It inhibits AR nuclear translocation and DNA binding, and impedes AR-mediated transcription.

Dosage: 240 mg (ie, four 60-mg tablets) PO once daily.

Approval was based on the phase 3 SPARTAN (Selective Prostate Androgen Receptor Targeting with ARN-509) trial. Investigators randomly assigned 806 men to receive treatment with apalutamide (240 mg/day) and 401 to receive placebo; all participants also received hormone therapy, either gonadotropin-releasing hormone analogue therapy or surgical castration.

All of the men had also undergone previous definitive treatment, either surgery or radiotherapy, for prostate cancer, but their PSA scores doubled within 10 months or less following treatment, despite hormone therapy.

Median MFS, which was the primary endpoint, was 40.5 months in the apalutamide group, as compared to 16.2 months in the placebo group (P <0.001). That translated into a 72% reduction in the relative risk for metastasis or death with the new drug (hazard ratio, 0.28; 95% CI: 0.23-0.35).



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