1 Marzo 2019

FDA Approval Sought for Darolutamide for Nonmetastatic CRPC

February 27, 2019 – A new drug application (NDA) has been filed with the FDA for darolutamide for the treatment of patients with nonmetastatic castration-resistant prostate cancer (CRPC), according to the codevelopers of the investigational agent, Bayer and Orion Corporation. The NDA is based on findings from the phase III ARAMIS trial, in which darolutamide added to androgen deprivation therapy (ADT) significantly improved metastasis-free survival (MFS) … (leggi tutto)