Abstract
The journey of Belzutifan towards the goal of getting its FDA approval for patients with refractory renal cell carcinoma has reached another milestone. The FDA has granted priority review to the supplemental new drug application (sNDA) for belzutifan. The sNDA seeks approval for the indication of patients with previously treated advanced renal cell carcinoma following immune checkpoint and anti-angiogenic therapies. The interim findings from LITESPARK-005(NCT04195750) demonstrates that the treatment with belzutifan led to a statistically significant and clinically meaningful improvement in progression-free survival (PFS) compared with everolimus in adult patients with advanced renal cell carcinoma whose disease progressed following PD-1/PD-L1 and VEGF tyrosine kinase inhibitor (TKI) treatments.
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