Submission of non-metastatic castration-resistant prostate cancer (nmCRPC) drug announced

Bayer HealthCare announced the completion of the rolling submission of a New Drug Application (NDA) to the FDA for the investigational drug BAY 1841788 (darolutamide). The submission, which was initiated in December 2018, is based on data from the Phase III ARAMIS trial in men with non-metastatic castration-resistant prostate cancer (nmCRPC). These data were recently presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium and published simultaneously in The New England Journal of Medicine.

Comment: Darolutamide is an investigational, non-steroidal androgen receptor antagonist with a chemical structure that binds to the receptor and exhibits antagonistic activity, thereby inhibiting the receptor function and the growth of prostate cancer cells. A Phase III study in metastatic hormone-sensitive prostate cancer (ARASENS) is ongoing. Darolutamide is not approved by the U.S. FDA, the European Medicines Agency or any other health authority.