Darolutamide

darolutamide

Oral androgen receptor inhibitor (Orion, Bayer), approved for advanced prostate cancer in more than 85 markets. Phase 3 DASL-HiCaP (ESMO, 24 October 2026, interim, sponsor-reported): added to ADT and radiotherapy in about 1,100 patients with high-risk localised prostate cancer, metastasis-free survival HR 0.42 (95% CI 0.27-0.66), 4-year MFS 95% vs 88%; OS HR 0.88 (0.49-1.59). Not approved in this setting.