Merck’s Welireg (belzutifan) Receives the US FDA’s Approval for the Treatment of Von Hippel-Lindau Disease Associated Tumors

August 16, 2021 Auto Bot regulatory 0

Shots:

  • The approval is based on open-label study 004 trial evaluates welireg (120 mg, qd) in patients with VHL-associated tumors including RCC, CNS hemangioblastomas, or pNET
  • The results showed ORR (49%), m-DoR had not reached, 56% were still responding after 12mos., m-TTR (8mos.) in 61 patients with VHL-associated RCC, Additionally, 24 & 12 patients with CNS hemangioblastomas & pNET demonstrates ORR (63%/ 83%), m-DoR had not reached, CR rate (4% & 17%), PR rate (58% & 76%), patients were still responding (73% & 50%) after 12 mos., m-TTR was 3 & 8mos.
  • Welireg is the first HIF-2α inhibitor therapy approved in the US and is expected to be available in early Sept’21

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

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