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FDA Approval Sought for Apalutamide in Metastatic Castration-Sensitive Prostate Cancer

Gina Columbus @ginacolumbusonc
Published: Monday, Apr 29, 2019

Craig Tendler, M

Craig Tendler, MD

A supplemental new drug application (sNDA) has been submitted to the FDA for the approval of apalutamide (Erleada) for use as a treatment of patients with metastatic castration-sensitive prostate cancer, according to Janssen, the manufacturer of the next-generation androgen receptor inhibitor.1



  1. Janssen Submits Application to U.S. FDA Seeking Approval of ERLEADA®(apalutamide) for Patients with Metastatic Castration-Sensitive Prostate Cancer. Janssen. Published April 29, 2019. Accessed April 29, 2019.
  2. Janssen Announces ERLEADA®(apalutamide) Phase 3 TITAN Study Unblinded as Dual Primary Endpoints Achieved in Clinical Program Evaluating Treatment of Patients with Metastatic Castration-Sensitive Prostate Cancer. Janssen. Published January 30, 2019. Accessed January 30, 2019.
  3. Small EJ, Saad F, Chowdhury S et al. SPARTAN, a phase 3 double-blind, randomized study of apalutamide (APA) versus placebo (PBO) in patients (pts) with nonmetastatic castration-resistant prostate cancer (nmCRPC). J Clin Oncol. 2018;36(suppl 6s; abstract 161).

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