Bayer gets closer to have darolutamide as a potential treatment option for men with nmCRPC

Bayer has completed rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug darolutamide after the Phase III ARAMIS trial in men with non-metastatic castration-resistant prostate cancer (nmCRPC).

Scott Z. Fields, M.D., senior vice president and head of Oncology Development at Bayer’s Pharmaceutical Division, said that the NDA submission is a key milestone bringing us closer to providing darolutamide as a potential treatment option for men with nmCRPC.”

Bayer has been granted Fast Track designation by the FDA for darolutamide in men with nmCRPC. Bayer is also in discussions with other health authorities regarding a submission of darolutamide. The compound is being developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company