U.S. FDA Approves WELIREG® Plus LENVIMA® Combination for Advanced Renal Cell Carcinoma

The U.S. Food and Drug Administration (FDA) has approved the dual oral regimen of WELIREG® (belzutifan) plus LENVIMA® (lenvatinib) for adult patients with advanced renal cell carcinoma with a clear cell component (ccRCC) who have been previously treated with a PD-1/PD-L1 inhibitor. This approval is based on data from the Phase 3 LITESPARK-011 trial, showing significant improvement in progression-free survival.