Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
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

Contributions

Date	Contributor	Description
2026-05-05	Van Allen lab	Initial curation of EMA's approval of Welireg (belzutifan)
2025-02-12	European Medicines Agency	Indication received approval from the European Commission.