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

 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

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

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

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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