14 December 2023 - Today, the FDA approved belzutifan (Welireg, Merck) for patients with advanced renal cell carcinoma 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, a direct, randomised, open-label trial of 746 patients with unresectable locally advanced or metastatic clear cell renal cell carcinoma that had progressed following both a PD-1 or PD-L1 checkpoint inhibitor and a VEGF-TKI.

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