FDA Grants Priority Review to Darolutamide in Nonmetastatic CRPC

April 29, 2019 – The FDA has granted a priority review designation to a new drug application (NDA) for darolutamide for use as a treatment for patients with nonmetastatic castration-resistant prostate cancer (CRPC). The NDA is based on data from the phase III ARAMIS trial, in which the investigational nonsteroidal androgen receptor antagonist was associated with a 59% reduction in the risk of metastases or death compared with placebo in this patient population … (leggi tutto)