Regulatory approval

Published by the Food and Drug Administration. Approved

Welireg is a hypoxia-inducible factor inhibitor indicated for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNETs), not requiring immediate surgery.

This is written in the approval document.

Citation

Merck Sharp & Dohme LLC. Welireg (belzutifan) [package insert]. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/215383s012lbl.pdf. Revised May 2025. Accessed May 6, 2026.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	VHL pathogenic variants	Renal Cell Carcinoma	Belzutifan
FDA (2)	VHL pathogenic variants	Central Nervous System Hemangioblastoma	Belzutifan
FDA (2)	VHL pathogenic variants	Pancreatic Neuroendocrine Tumor	Belzutifan

Contributions

Date	Contributor	Description
2026-05-06	Van Allen lab	Initial curation of FDA's approval of Welireg (belzutifan)
2021-08-13	Food and Drug Administration	Indication received traditional approval.