{"title":"HIF Pathway Inhibition hold much promise and Point Toward an expanding RCC Armamentarium","authors":"Senthil Pazhanisamy","doi":"10.52733/kcj21n3-e","DOIUrl":null,"url":null,"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.","PeriodicalId":74040,"journal":{"name":"Kidney cancer journal : official journal of the Kidney Cancer Association","volume":"72 1","pages":"0"},"PeriodicalIF":0.0000,"publicationDate":"2023-10-06","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Kidney cancer journal : official journal of the Kidney Cancer Association","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.52733/kcj21n3-e","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
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.