获得加速批准的抗癌药物适用性撤回的预测因素:一个追溯队列研究

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Ariadna Tibau1,2,3,4, Edward R Scheffer Cliff1,2,5,6, Alejandra Romano3,4

  • 1Program on Regulation, Therapeutics, And Law (PORTAL), Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, Boston, Massachusetts, USA.

EClinicalMedicine
|July 21, 2025
PubMed
概括

通过加速途径批准的具有较低临床益处的药物更有可能被撤回. 突破性疗法名称和基因组向疗法显示更低的戒断率,表明持续的益处.

关键词:
加快审批的方法是加速审批.癌症治疗治疗 癌症治疗药物戒断 药物戒断 是一种欧洲医学瘤学会 - 临床益处尺度的大小 (ESMO-MCBS)美国食品和药物管理局 (FDA)

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