Merck Reports the US FDA’s Acceptance of NDA for Priority Review of Belzutifan (MK-6482) to Treat Patients with Von Hippel-Lindau Disease Associated RCC

March 16, 2021 Auto Bot Acceptance, FDA, Merck, NDA, patients, Priority Review, regulatory, reports, Treat 0

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

Click here ­to­ read full press release/ article | Ref: Merck | Image: AP News

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