FDA Grants Apalutamide Priority Review for Nonmetastatic CRPC

December 21, 2017 – 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. The NDA is based on data from the phase III SPARTAN trial (ARN-509-003), which evaluated the safety and efficacy of apalutamide versus … (leggi tutto)