The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending marketing authorisation for darolutamide, in combination with androgen deprivation therapy (ADT), for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the European Union. This recommendation, announced by Orion’s partner Bayer, is based on results from the pivotal Phase III ARANOTE trial.
The ARANOTE study demonstrated that adding darolutamide to ADT significantly lowered the risk of radiological progression or death by 46% compared to placebo plus ADT (Hazard Ratio 0.54; 95% CI 0.41–0.71; P<0.0001). The European Commission is expected to make a final decision on the marketing authorisation in the coming months.
If approved, this expanded indication would offer physicians greater flexibility to individualize treatment plans, allowing the use of darolutamide plus ADT with or without chemotherapy (docetaxel) based on individual patient needs.
Darolutamide, an oral androgen receptor inhibitor (ARi), is already approved in more than 85 countries under the brand name Nubeqa®. In June 2025, the U.S. Food and Drug Administration (FDA) approved darolutamide in combination with ADT for mHSPC, with or without chemotherapy, making it the first and only ARi with this approval in the United States. It is also approved in combination with ADT and docetaxel for mHSPC and as monotherapy with ADT in non-metastatic castration-resistant prostate cancer (nmCRPC) in patients at high risk of disease progression.
Prostate cancer remains a major global health concern, ranking as the second most common cancer and the fifth leading cause of cancer-related deaths among men worldwide. In 2022, approximately 1.5 million men were newly diagnosed with prostate cancer, with nearly 397,000 deaths reported globally. In Europe alone, around 474,000 new cases and 115,000 deaths were estimated in 2022. Projections suggest prostate cancer diagnoses could rise to 2.9 million by 2040.
The positive CHMP opinion represents a significant step forward in expanding treatment options for patients with advanced prostate cancer in Europe.