The US Food and Drug Administration (FDA) has granted priority review status to an indication extension application filed by Merck, Sharp & Dohme (MSD; NYSE: MRK) for its oral HIF-2α inhibitor Welireg (belzutifan). The application seeks approval for the treatment of advanced renal cell carcinoma (RCC) in adults who have not responded to immune checkpoint or antiangiogenic therapies. The FDA anticipates making a decision on the application in January next year.
Supporting Data and Impact
The priority review status is supported by interim results from a Phase III study demonstrating that Welireg improved progression-free survival (PFS) and objective response rate (ORR) compared to the antiangiogenic therapy everolimus. This data suggests that Welireg could offer a significant therapeutic advantage for patients with advanced RCC who have exhausted other treatment options.
Existing Approvals for Welireg
Welireg is already approved in the United States for the treatment of RCC-associated von Hippel-Lindau (VHL) disease, central nervous system (CNS) hemangioblastomas, and pancreatic neuroendocrine tumors (pNET). The extension of its indication, if approved, would further expand the drug’s utility in oncology.-Fineline Info & Tech
