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FDA Approval Sought for Apalutamide in Prostate Cancer

Jason Harris
Published: Wednesday, Oct 11, 2017

Peter F. Lebowitz, MD, PhD
Peter F. Lebowitz, MD, PhD
A new drug application (NDA) has been submitted to the FDA for apalutamide (ARN-509) for the treatment of patients with non-metastatic castration-resistant prostate cancer (CRPC), according to Janssen Biotech, the manufacturer of the next-generation oral androgen receptor inhibitor.

Researchers chose 240 mg of daily apalutamide as the maximum effective dose, which was the regimen used in the SPARTAN trial.
Rathkopf DE, Morris MJ, Fox JJ, et al. Phase I study of ARN-509, a novel antiandrogen, in the treatment of castration-resistant prostate cancer. J Clin Oncol. 2013;31:3525-3530.

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