Welireg (belzutifan) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

Citation

Merck Sharp & Dohme B.V. Welireg (belzutifan) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/welireg-epar-product-information_en.pdf.pdf. Revised January 2026. Accessed May 5, 2026.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
Welireg is indicated as monotherapy for the treatment of adult patients with von Hippel-Lindau disease who require therapy for associated, localised renal cell carcinoma (RCC), central nervous system (CNS) haemangioblastomas, or pancreatic neuroendocrine tumours (pNET), and for whom localised procedures are unsuitable.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s)	Biomarker(s)	Cancer type	Therapy(ies)
EMA (1)	VHL pathogenic variants	Renal Cell Carcinoma	Belzutifan
EMA (1)	VHL pathogenic variants	Central Nervous System Hemangioblastoma	Belzutifan
EMA (1)	VHL pathogenic variants	Pancreatic Neuroendocrine Tumor	Belzutifan