- EU approves darolutamide with ADT for mHSPC based on Phase III ARANOTE trial.
- Darolutamide reduces risk of radiological progression or death by 46%.
- Already approved in over 85 countries for mHSPC and nmCRPC.
- Developed by Bayer and Orion Corporation.
EU Approval for Darolutamide
The European Commission has approved the use of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC). This decision is based on the positive outcomes of the Phase III ARANOTE trial.
Clinical Trial Results
The ARANOTE trial demonstrated that darolutamide, when combined with ADT, significantly reduced the risk of radiological progression or death by 46% compared to placebo plus ADT. The trial's results underscore the efficacy and safety of darolutamide for prostate cancer patients.
Global Approvals
Darolutamide, marketed under the brand name Nubeqa™, is already approved in over 85 countries. It is used with ADT and docetaxel for mHSPC and with ADT alone for non-metastatic castration-resistant prostate cancer (nmCRPC) in patients at high risk of developing metastatic disease.
Prostate Cancer Statistics
Prostate cancer is the second most common cancer in men worldwide and the fifth leading cause of cancer death. In 2022, approximately 1.5 million men were diagnosed globally, with about 397,000 deaths. In Europe, there were nearly 474,000 new cases and approximately 115,000 deaths in 2022. Projections indicate diagnoses could rise to 2.9 million by 2040.
Development Partnership
Darolutamide is developed through a collaboration between Bayer and Orion Corporation, a Finnish pharmaceutical company. This partnership aims to enhance treatment options for men with advanced prostate cancer.
