Belzutifan: First Approval
Belzutifan: First Approval
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DOI：
10.1007/s40265-021-01606-x
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发表时间：
2021-10-06
期刊：
影响因子：
11.5
通讯作者：
Deeks, Emma D.
中科院分区：
文献类型：
--
作者：
Deeks, Emma D.
Belzutifan（Welireg（TM））是一种口服小分子缺氧诱导因子（HIF）-2 α抑制剂，由Peloton Therapeutics开发，用于治疗实体瘤，包括肾细胞癌（RCC）与透明细胞组织学（ccRCC）和von Hippel-Lindau（VHL）疾病相关RCC。2021年8月，Belzutifan在美国首次获得批准，用于治疗需要治疗相关RCC、中枢神经系统（CNS）血管母细胞瘤或胰腺神经内分泌肿瘤（pNET）的VHL疾病患者，无需立即手术。在其他适应症（包括ccRCC、pNET和嗜铬细胞瘤/副神经节瘤）中，贝珠替凡（作为单药治疗或联合治疗）的临床研究也在多个国家进行。本文总结了贝珠替凡开发的里程碑，导致首次批准用于某些VHL疾病相关肿瘤。
Belzutifan (Welireg (TM)) is an oral small molecule inhibitor of hypoxia-inducible factor (HIF)-2 alpha being developed by Peloton Therapeutics for the treatment of solid tumours, including renal cell carcinoma (RCC) with clear cell histology (ccRCC) and von Hippel-Lindau (VHL) disease-associated RCC. In August 2021, belzutifan received its first approval in the USA for the treatment of patients with VHL disease who require therapy for associated RCC, central nervous system (CNS) haemangioblastomas or pancreatic neuroendocrine tumours (pNET), not requiring immediate surgery. Clinical studies of belzutifan (as monotherapy or combination therapy) in other indications, including ccRCC, pNET and phaeochromocytoma/paraganglioma, are also underway in various countries. This article summarizes the milestones in the development of belzutifan leading to this first approval for certain VHL disease-associated tumours.