Merck's Belzutifan Wins FDA Approval As First Drug For Rare VHL Tumors

The FDA on Friday approved Merck & Co Inc's MRK belzutifan for patients with the rare disorder known as von Hippel-Lindau (VHL) disease.
VHL is a rare genetic disease that causes tumors and cysts to grow throughout the body.
Belzutifan was one of the most lucrative assets Merck picked up through its 2019 Peloton buy.
The FDA's decision comes well ahead of the expected September 15 action date, and it includes a surprisingly broader label beyond just renal cell carcinoma patients.
Belzutifan, marketed as Welireg, is intended for VHL patients who require therapy for associated renal cell carcinoma, central nervous system hemangioblastomas, or pancreatic neuroendocrine tumors but don't immediately require surgery.
The drug blocks HIF-2α (hypoxia-inducible factor-2 alpha), a protein that plays a role in regulating tissue oxygen levels.
Proteins known as hypoxia-inducible factors, including HIF-2α, can accumulate in patients whose bodies don't correctly regulate them, leading to the proliferation of red blood cells and, eventually, cancers.
Price Action: MRK shares closed higher at 0.89% at $76.72 on Friday.
Related content: Benzinga's Full FDA Calendar.