NDA submitted for non-metastatic castration-resistant PCa agent
Janssen Biotech, Inc. has submitted a new drug application to the FDA for apalutamide, an investigational, next-generation oral androgen receptor inhibitor for men with non-metastatic castration-resistant prostate cancer (CRPC). The submission is based on phase III data from the pivotal ARN-509-003 (SPARTAN) clinical trial, which assessed the safety and efficacy of apalutamide versus placebo in men with non-metastatic CRPC who have a rapidly rising PSA despite receiving continuous androgen deprivation therapy. The primary endpoint of the study was metastasis-free survival. SPARTAN study results will be presented at a future medical meeting, according to Janssen Biotech.
Priority review granted for advanced renal cell carcinoma agent
The FDA has determined Exelixis, Inc.’s supplemental new drug application for cabozantinib (CABOMETYX) for patients with previously untreated advanced renal cell carcinoma (RCC) to be sufficiently complete to permit a substantive review. The FDA granted priority review of the filing and assigned a Prescription Drug User Fee Act action date of Feb. 15, 2018. The application is based on data from CABOSUN, a randomized phase II trial conducted by The Alliance for Clinical Trials in Oncology as part of Exelixis’ collaboration with the National Cancer Institute’s Cancer Therapy Evaluation Program. CABOMETYX was previously approved by the FDA on April 25, 2016 for the treatment of patients with advanced RCC who have received prior anti-angiogenic therapy.