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

The U.S. Food and Drug Administration (FDA) has approved WELIREG (belzutifan) in combination with LENVIMA (lenvatinib) for certain adult patients with previously treated advanced renal cell carcinoma with a clear cell component (ccRCC). This approval is based on results from the Phase 3 LITESPARK-011 trial and marks the first approved combination of a HIF-2 alpha inhibitor and a multi-targeted VEGFR-TKI for this patient population.