Shots:

• The NDA is based on P-II study-004 trial involves assessing Belzutifan (120 mg- PO- qd) in 61 patients with VHL disease who had at least one measurable solid tumor localized to the kidney and did not require immediate surgery
• Results: It showed ORR of 36.1% while the 2EPs include DCR- DoR- time to response- PFS- time to surgery- and safety. The anticipated PFUFA date is Sept 15- 2021
• Belzutifan (MK-6482) is a selective HIF-2α inhibitor- currently being evaluated in a P-III trial as monothx. and in combination regimen in 1L treatment for advanced RCC. The NDA filing will expand and diverse Merck’s oncology portfolio

 ­ Ref: Merck | Image: Merck