European Commission Approves Darolutamide Plus ADT for Metastatic Hormone-Sensitive Prostate Cancer

The European Commission has granted marketing authorization to darolutamide (Nubeqa) combined with androgen deprivation therapy (ADT) for treating metastatic hormone-sensitive prostate cancer (mHSPC).This approval, following a positive opinion from the European Medicines Agency in June 2025, allows darolutamide plus ADT to be used with or without docetaxel, offering clinicians greater flexibility in tailoring treatment. The U.S. FDA also approved this combination in June 2025.The decision is supported by the phase 3 ARANOTE trial (NCT04736199), a double-blind study of 669 patients randomized 2:1 to receive darolutamide (600 mg twice daily) plus ADT or placebo plus ADT. The primary endpoint, radiographic progression-free survival (rPFS), showed a 46% reduction in progression or death risk with darolutamide (HR, 0.54; 95% CI, 0.41–0.71; P < .0001). At 24 months, rPFS was 70.3% for darolutamide versus 52.1% for placebo. Secondary endpoints, including time to castration-resistant prostate cancer (HR, 0.40) and PSA progression (HR, 0.31), also favored darolutamide.

Published in the Journal of Clinical Oncology, these results highlight darolutamide’s efficacy in delaying disease progression in mHSPC, enhancing treatment options for this patient population.

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