Posted by Michael Wonder on 10 Mar 2019
Bayer submits European marketing authorisation application for darolutamide
8 March 2019 - Third submission for darolutamide in two weeks underscores Bayer's commitment to fill an unmet need for men with non-metastatic castration-resistant prostate cancer worldwide.
Bayer has submitted a marketing authorisation application to the EMA for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC).
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 in San Francisco and published simultaneously in The New England Journal of Medicine, showing a statistically significant improvement in metastasis-free survival for darolutamide plus androgen deprivation therapy.
