Darolutamide submitted for European marketing authorization

Finnish drugmaker Orion Corp (Nasdaq OMX: ORNAV) and Germany’s Bayer (BAYN: DE) have filed a marketing authorization applications with the European Medicines Agency for their jointly-developed darolutamide for the treatment of patients with non-metastatic castration resistant prostate cancer (nmCRPC).

This is the third submission for darolutamide in two weeks, which the firms say underscores Orion's and Bayer's commitment to fill an unmet need for men with nmCRPC worldwide.

The submission to the EMA is based on data from the Phase III ARAMIS trial in men with nmCRPC, which were recently presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco and published simultaneously in The New England Journal of Medicine, showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT).1