FDA approves Merck-Eisai Welireg-Lenvima combination for previously treated advanced kidney cancer

On September 24, 2026, the U.S. FDA approved Merck’s Welireg (belzutifan) plus Eisai’s Lenvima (lenvatinib) for adults with advanced renal cell carcinoma containing a clear-cell component after treatment with a PD-1 or PD-L1 inhibitor.

The approval was based on the Phase 3 LITESPARK-011 trial, which compared the combination with cabozantinib.

Welireg-Lenvima reduced the risk of disease progression or death by 26% versus cabozantinib. Median progression-free survival was 14.6 months versus 10.6 months, and objective response rates were 53% versus 40%.

The regimen is the first approved combination in this setting pairing a HIF-2α inhibitor with a multi-targeted VEGFR tyrosine-kinase inhibitor.

The recommended regimen is Welireg 120 mg plus Lenvima 20 mg once daily, continued until disease progression or unacceptable toxicity. Overall survival did not reach statistical significance at the final analysis.