Welireg (belzutifan) [package insert]. FDA.

Regulatory approval published by the Food and Drug Administration.

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.

Regulatory approvals

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

Indication	Statements
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.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

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