Merck KGaA and Eisai received U.S. Food and Drug Administration (FDA) approval for WELIREG (belzutifan) in combination with LENVIMA (lenvatinib). The treatment is approved for adults with advanced clear cell renal cell carcinoma following prior therapy with a PD-1 or PD-L1 inhibitor.
The approval was based on the Phase 3 LITESPARK-011 trial, in which the combination reduced the risk of disease progression or death by 26% compared with cabozantinib. The combination targets different biological pathways and offers a new treatment option for people with this type of advanced kidney cancer.