Merck: FDA Grants Priority Review For NDA For Belzutifan - Quick Facts

(RTTNews) - Merck (MRK) said FDA has granted priority review for a New Drug Application for the hypoxia-inducible factor-2 alpha inhibitor belzutifan, an investigational candidate for the treatment of patients with von Hippel-Lindau disease-associated renal cell carcinoma, not requiring immediate surgery. The FDA has set a PDUFA, or target action, date of September 15, 2021.

Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories, stated: "This priority review validates the important progress we have made to expand and diversify Merck's oncology pipeline with innovative, new therapeutic approaches. We look forward to working closely with the FDA to bring belzutifan to patients in need."