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

  Ref: Merck | Image: Merck