Posted by Michael Wonder on 03 Feb 2020
Bayer receives positive CHMP opinion for darolutamide as a new treatment for men with non-metastatic castration-resistant prostate cancer
31 January 2020 - CHMP opinion is based on Phase III ARAMIS trial data evaluating the efficacy and safety of darolutamide plus androgen deprivation therapy (ADT) compared to placebo plus ADT.
The CHMP) of the European Medicines Agency has recommended darolutamide, a non-steroidal androgen receptor inhibitor (ARi), for marketing authorization in the European Union.
The compound, which is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, is recommended for the treatment of men with non-metastatic castration-resistant prostate cancer, who are at high risk of developing metastatic disease.
The final decision from the European Commission on the marketing authorization is expected in the coming months.
