Merck Receives Positive EU CHMP Opinion for WELIREG® (belzutifan) in Combination With Lenvatinib for Adults With Advanced Renal Cell Carcinoma With a Clear Cell Component (ccRCC) Following Treatment With an Anti-PD-1/PD-L1 Therapy
Business Wire•13/11/2026•06:35 ET
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Key Highlights
- ➤EU CHMP recommends WELIREG plus lenvatinib approval for advanced ccRCC
- ➤Final European Commission marketing decision expected within two months
- ➤LITESPARK-011 cut progression or death risk 26% versus cabozantinib
- ➤Overall survival failed statistical significance; death risk fell 15%
- ➤Response rate reached 53.1% versus 40.2%; duration doubled to 22.0 months
Expert Statements
Christina Derleth, Vice President, Global Oncology Clinical Development, Merck Research Laboratories
“Patients with advanced renal cell carcinoma in the European Union have limited treatment options if their disease progresses following anti-PD-1 or anti-PD-L1 therapy,”
Christina Derleth, Vice President, Global Oncology Clinical Development, Merck Research Laboratories
“This positive opinion is a meaningful step toward potentially bringing this first-of-its-kind regimen to patients in need in the European Union and underscores the important role of WELIREG plus lenvatinib as a new option in the treatment of renal cell carcinoma.”
Merck Receives Positive EU CHMP Opinion for WELIREG® (belzutifan) in Combination With Lenvatinib for Adults With Advanced Renal Cell Carcinoma With a Clear Cell Component (ccRCC) Following Treatment With an Anti-PD-1/PD-L1 Therapy
Opinion granted based on positive progression-free survival results from the Phase 3 LITESPARK-011 trial
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