Posted by Michael Wonder on 27 Jan 2025
FDA grants priority review to Merck’s application for Welireg (belzutifan) for the treatment of patients with advanced pheochromocytoma and paraganglioma
27 January 2025 - Acceptance based on objective response rate data from the Phase 2 LITESPARK-015 trial evaluating WELIREG in certain patients with advanced PPGL.
Merck today announced the US FDA has accepted for priority review a supplemental new drug application seeking approval of Welireg (belzutifan), Merck’s oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, for the treatment of adult and paediatric patients (12 years and older) with advanced, unresectable, or metastatic pheochromocytoma and paraganglioma.
