FDA Approves Belzutifan Plus Lenvatinib for Advanced Clear Cell Renal Cell Carcinoma After PD-1/PD-L1 Therapy

On September 24, 2026, the FDA approved Merck's belzutifan (Welireg) with Eisai's lenvatinib (Lenvima) for adults with advanced renal cell carcinoma with a clear cell component following a PD-1 or PD-L1 inhibitor. In the open-label phase 3 LITESPARK-011 trial (747 patients), median PFS was 14.6 months with the combination versus 10.6 months with cabozantinib, a 26% relative reduction in risk of progression or death. Belzutifan carries a boxed warning for embryo-fetal toxicity; the combination adds cardiac dysfunction warnings.