Orion says Bayer reports CHMP recommends third indication for darolutamide

Orion’s (ORINY) collaboration partner Bayer (BAYRY) announced that the Committee for Medicinal Products for Human Use of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor, plus androgen deprivation therapy for marketing authorisation in the European Union for the treatment of patients with metastatic hormone-sensitive prostate cancer. The CHMP recommendation is based on positive results from the pivotal Phase III ARANOTE trial which showed that darolutamide plus ADT significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT in patients with mHSPC. A final decision on marketing authorisation from the European Commission is anticipated in the coming months. The U.S. Food and Drug Administration recently approved darolutamide in combination with ADT for mHSPC in June 2025, making it the first and only in the US and FDA-approved ARi for the treatment of patients with mHSPC, in combination with ADT, with or without chemotherapy. Darolutamide, under the brand name Nubeqa, is approved in over 85 countries for use with ADT and docetaxel in mHSPC, and with ADT alone in non-metastatic castration-resistant prostate cancer in patients who are at high risk of developing metastatic disease. Darolutamide is developed jointly by Orion and Bayer.