CHMP recommends third indication for darolutamide for patients with advanced prostate cancer
ORION CORPORATION PRESS RELEASE 20 JUNE 2025 at 13.30 EESTÂ Â Â Â Â Â Â Â Â Â
CHMP recommends third indication for darolutamide for patients with advanced prostate cancer
- CHMP adopts positive opinion for the marketing authorisation of darolutamide in combination with androgen deprivation therapy (ADT) for patients with metastatic hormone-sensitive prostate cancer (mHSPC) in the European Union.
- Positive opinion is based on results from the pivotal Phase III ARANOTE trial.
- Pending approval, this broadened indication would give doctors the option to use darolutamide plus ADT, with or without chemotherapy (docetaxel), offering greater flexibility to tailor treatment plans to meet mHSPC patients’ needs.
Orion’s collaboration partner Bayer announced today that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended darolutamide, an oral androgen receptor inhibitor (ARi), plus androgen deprivation therapy (ADT) for marketing authorisation in the European Union (EU) for the treatment of patients with metastatic hormone-sensitive prostate cancer (mHSPC). 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 (HR 0.54; 95% CI 0.41–0.71; P
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