The FDA approved belzutifan (Welireg, Merck) for patients with advanced renal cell carcinoma (RCC) following a programmed death receptor-1 (PD-1) or programmed death ligand-1 (PD-L1) inhibitor and a vascular endothelial growth factor tyrosine kinase inhibitor (VEGF-TKI).
Efficacy was evaluated in LITESPARK-005 (ClinicalTrials.gov Identifier: NCT04195750), an open-label, randomized, head-to-head trial of 746 patients with unresectable locally advanced or metastatic clear cell RCC that had