EMA’s CHMP Adopts Positive Opinion Recommending Approval Of Merck’s WELIREG Plus Lenvatinib For Treatment Of Advanced Renal Cell Carcinoma With Clear Cell Component; Final Decision Expected In Next Two Months

Opinion granted based on positive progression-free survival results from the Phase 3 LITESPARK-011 trial

If approved, this regimen will be the first and only approved combination of a HIF-2α inhibitor and a multi-targeted VEGFR-TKI in the European Union

Merck (NYSE:MRK), known as MSD outside of the United States and Canada, today announced the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending approval of WELIREG® (belzutifan), Merck’s first-in-class oral hypoxia-inducible factor-2 alpha (HIF-2α) inhibitor, plus lenvatinib, the orally available multiple receptor tyrosine kinase inhibitor (TKI) discovered by Eisai, for the treatment of adult patients with advanced renal cell carcinoma with a clear cell component (ccRCC) following a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor. This recommendation will now be reviewed by the European Commission (EC) for marketing authorization in the European Union (EU), Iceland, Liechtenstein and Norway. A final decision is expected in the next two months.