FDA Approval Alert: The Need-to-Know | Belzutifan in Adult/Pediatric Pheochromocytoma and Paraganglioma

In May 2025, the FDA approved belzutifan for the treatment of adult and pediatric patients 12 years or older with advanced, unresectable, or metastatic pheochromocytoma or paraganglioma.

Data from the LITESPARK-015 trial supported the FDA’s decision to approve belzutifan monotherapy in patients with advanced, unresectable, or metastatic PPGL.
FDA Approves Belzutifan in Adult/Pediatric Pheochromocytoma and Paraganglioma
Article
May 14, 2025 4:25 PM
Data from the LITESPARK-015 trial supported the FDA’s decision to approve belzutifan monotherapy in patients with advanced, unresectable, or metastatic PPGL.