2026-09-28 Eisai Co.,Ltd. “The combination therapy of Lenvima® (lenvatinib) and Wellireg® (verzutifan) has been approved by the U.S. FDA for adult patients with previously treated advanced clear cell renal cell carcinoma. This approval is based on the results of the Phase III clinical trial "LITESPARK-011," which evaluated the combination therapy of Lenvima and Wellireg compared to cabozantinib in patients with advanced clear cell renal cell carcinoma (ccRCC) who had previously received treatment with PD-1/PD-L1 inhibitors. The combination of Lenvima and Wellireg is the first combination therapy of a multi-target VEGFR tyrosine kinase inhibitor and an HIF-2α inhibitor to be approved in ccRCC patients.”