The FDA has granted a priority review to a new drug application (NDA) for apalutamide (ARN-509) for the treatment of patients with nonmetastatic 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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