截至2023年4月，自1992年以来，美国食品药物管理局（FDA）对于癌症适应症共批准了23项加速批准，并于过去3年中有17项（占总数的74%）被撤回。这些适应症在欧盟的市场批准情况尚未报告。我们通过对FDA和欧洲药品管理局（EMA）的相关文件进行审查，旨在调查被FDA撤回的癌症加速批准是否在欧盟获得了市场批准，并比较EMA和FDA对这些适应症的批准历史。截至2023年4月20日，美国共有23项撤回的加速批准癌症适应症中，有9项（占总数的39%）在欧盟获得了类似适应症的市场批准。相比之下，欧盟只撤销了两个癌症适应症的条件性市场批准，这两个适应症在美国已不再批准。这些发现表明FDA和EMA之间在批准政策上存在差异，并暗示着美国的某些患者群体无法获得相关的医疗治疗，或者欧盟的某些患者群体在没有积极的利益风险平衡情况下接受药物治疗。通过增加两个机构之间的合作和信息共享，这些差异有望得到减少。 版权所有 © 2023 Elsevier Ltd. 保留所有权利。

As of April, 2023, 23 accelerated approvals for cancer indications granted by the US Food and Drug Administration (FDA) since 1992 have been withdrawn from the US market, with 17 (74%) of 23 withdrawn in the past 3 years. The marketing authorisation status of these indications in the EU has not been reported. A review of relevant documents from the FDA and the European Medicines Agency (EMA) was done to investigate whether the accelerated approvals for cancer indications withdrawn by the FDA have a marketing authorisation in the EU to date, and to compare the approval history of these indications by the EMA and FDA. We found that, as of April 20, 2023, nine (39%) of 23 withdrawn accelerated approvals for cancer indications in the USA have a marketing authorisation in the EU for a similar indication. By comparison, only two conditional marketing authorisations for cancer indications have been withdrawn from the EU; both are no longer approved in the USA. These findings indicate a discrepancy in the approval policies between the FDA and EMA and imply either that some patient groups in the USA do not get access to relevant medical treatment, or that some patient groups in the EU are treated with medicine without a positive benefit-risk balance. These discrepancies could potentially be reduced by increased collaboration and information sharing between the two agencies.Copyright © 2023 Elsevier Ltd. All rights reserved.