Welireg bags two indication nods from EC

18 February 2025

US pharma giant Merck & Co (NYSE: MRK) today announced that the European Commission (EC) has conditionally approved two indications for Welireg (belzutifan), its oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor.

Welireg is authorized as monotherapy for the treatment of adult patients with von Hippel-Lindau (VHL) disease who require therapy for associated, localized renal cell carcinoma (RCC), central nervous system (CNS) hemangioblastomas, or pancreatic neuroendocrine tumors (pNET), and for whom localized procedures are unsuitable.

Additionally, it is cleared for the treatment of adult patients with advanced clear cell RCC that progressed following two or more lines of therapy that included a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and at least two vascular endothelial growth factor (VEGF) targeted therapies.

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