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Lessons from withdrawn accelerated approvals in oncology
Nature Cancer ( IF 22.7 ) Pub Date : 2024-01-30 , DOI: 10.1038/s43018-023-00696-8
George S. Mellgard , Tito Fojo , Susan E. Bates

Drug regulatory agencies in the USA and Europe have mechanisms to provide patients faster access to novel treatments, expecting that follow-up trials will confirm clinically meaningful results. However, some early approvals are subsequently withdrawn. Here we discuss the insights gained from withdrawn accelerated approvals for oncologic agents in the past decade.

中文翻译:

撤回肿瘤学加速审批的教训

美国和欧洲的药物监管机构拥有为患者提供更快获得新疗法的机制,期望后续试验将证实具有临床意义的结果。然而,一些早期批准随后被撤回。在这里,我们讨论了过去十年从撤回的肿瘤药物加速审批中获得的见解。
更新日期:2024-01-30
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