Posted by Michael Wonder on 31 Mar 2020
Nubeqa (darolutamide) receives EU approval as a new treatment for men with non-metastatic castration-resistant prostate cancer
30 March 2020 - Approval is based on Phase III ARAMIS trial results showing a statistically significant improvement in metastasis-free survival (MFS) for darolutamide plus androgen deprivation therapy (ADT) versus placebo plus ADT, and a favourable safety profile.
Bayer today announced that the European Commission has granted marketing authorization in the European Union (EU) for Nubeqa (darolutamide), an oral androgen receptor inhibitor.
The compound, which is developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company, is indicated for the treatment of men with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease. Bayer is responsible for global commercialisation, with a co-promotion of Bayer and Orion Corporation in certain European markets, e.g. France, Germany, Italy, Spain, the UK, Scandinavia and Finland.
