Belzutifan for renal cell carcinoma: Balancing regulatory approval with societal and patient impact.

LITESPARK-005 evaluated belzutifan against everolimus in advanced renal cell carcinoma (RCC),1 demonstrating significant progression-free survival improvement but failing to meet the overall survival (OS) co-primary endpoint. Despite FDA approval, the trial highlights key obstacles in drug development in RCC, given the absence of OS improvement, lack of biomarker studies, high financial toxicity, and limited accessibility outside the United States.