Nubeqa™ (darolutamide) receives EU approval for additional indication in prostate cancer.

Diegem, March 10, 2023 – The European Commission has granted marketing authorization in the European Union (EU) for Nubeqa TM (darolutamide), an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) in combination with docetaxel, for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). Nubeqa™ is already approved for the treatment of patients with non-metastatic castration-resistant prostate cancer (nmCRPC), who are at high risk of developing metastatic disease.