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Merck

Merck Receives the EC’s Approval for Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma

Shots:The EC has approved Welireg for VHL-related localized RCC, CNS hemangioblastomas, or pNET unsuitable for localized procedures and advanced ccRCC post-PD-1/PD-L1 inhibitors or VEGF therapies progression across EU member states, as well as Iceland, Liechtenstein & Norway Approval for VHL-related tumors was based on P-II (LITESPARK-004) study (n=61), showing ORR of 49% (all…

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MERCK

 Merck Reports the CHMP’s Positive Opinion of Welireg (Belzutifan) for Von Hippel-Lindau (VHL) Disease-Associated Tumors and Previously Treated Renal Cell Carcinoma 

Shots:    The CHMP has recommended conditional approval of Welireg for VHL-related localized RCC, CNS hemangioblastomas or pNET unsuitable for localized procedures and advanced ccRCC post PD-1/PD-L1 inhibitors or VEGF therapies progression. EC’s decision is anticipated in Q1’25 Opinion for VHL-related tumors was based on LITESPARK-004 study (n=61), showing ORR of 49% (all PRs), with 56%…

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