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% maintaining response (RCC); 63% (CR: 4%, PR: 58%), with 73% maintaining response (CNS hemangioblastomas) & 83% (CR: 17%, PR: 67%), with 50% maintaining response for ≥12mos. (pNET); mDoR not reached 

• Opinion for ccRCC was based on P-III (LITESPARK-005) study (n=746), depicting reduced disease progression or death risk by 25% vs everolimus, with mPFS of 5.6mos., ORR of 22% (CR: 3%, PR: 19%) vs 4% (PR: 4%) 

Ref: Merck | Image: Merck | Press Release

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