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.

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
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