FDA approves Welireg and Lenvima combination for advanced kidney cancer

The FDA approved belzutifan (Welireg) with lenvatinib (Lenvima) on September 24, 2026, for adults with advanced renal cell carcinoma with a clear cell component (ccRCC) after a PD-1 or PD-L1 inhibitor. The indication covers locally advanced or metastatic disease that progressed on or after that treatment, or within six months of completing adjuvant PD-1 therapy.

The FDA based approval on LITESPARK-011, an open-label, randomized trial of 747 patients assigned 1:1 to the combination or cabozantinib. Median progression-free survival was 14.6 months with the combination and 10.6 months with cabozantinib, with a hazard ratio of 0.74 (95% CI: 0.61, 0.89). The final overall survival analysis was not statistically significant. Median overall survival was 33.7 months and 28.6 months, respectively.

The belzutifan prescribing information includes a boxed warning for embryo-fetal toxicity and warnings for anemia and hypoxia. The FDA said warnings for the combination also include cardiac dysfunction.