Welireg FDA Approval History
Last updated by Judith Stewart, BPharm on Jan 2, 2024.
FDA Approved: Yes (First approved August 13, 2021)
Brand name: Welireg
Generic name: belzutifan
Dosage form: Tablets
Company: Merck
Treatment for: Von Hippel-Lindau Syndrome, Renal Cell Carcinoma
Welireg (belzutifan) is a selective inhibitor of hypoxia-inducible factor 2 alpha (HIF-2α) for the treatment of von Hippel-Lindau (VHL) disease and advanced renal cell carcinoma.
- Welireg is indicated:
- for 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 (pNET), not requiring immediate surgery.
- for treatment of adult patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI). - Von Hippel-Lindau disease is a rare genetic disease caused by a genetic mutation in the VHL tumor suppressor gene. When VHL is inactivated, proteins known as hypoxia-inducible factors can accumulate, leading to the growth of both benign and malignant tumors.
Renal cell carcinoma is the most common type of kidney cancer. Advanced renal cell carcinoma means the cancer has spread to another part of the body. - Welireg works by reducing transcription and expression of hypoxia-inducible factor 2 alpha (HIF-2α) target genes associated with cellular proliferation, angiogenesis and tumor growth.
- Welireg tablets are administered once daily with or without food.
- Welireg may cause serious side effects including anemia and hypoxia.
- Common adverse reactions in VHL disease include decreased hemoglobin, fatigue, increased creatinine, headache, dizziness, increased glucose, and nausea.
Common adverse reactions in advanced renal cell carcinoma include decreased hemoglobin, fatigue, musculoskeletal pain, increased creatinine, decreased lymphocytes, increased alanine aminotransferase, decreased sodium, increased potassium, and increased aspartate aminotransferase.
Development timeline for Welireg
Further information
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