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美国加速批准新抗癌药物对欧盟和日本获益验证和监管批准时间的影响。

Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan.

机构信息

Department of Clinical Medicine, Pharmaceutical Medicine, Graduate School of Pharmaceutical Sciences, Kitasato University, 5-9-1, Shirokane, Minato-Ku, Tokyo, Japan.

Daiichi Sankyo Co., Ltd., Tokyo, Japan.

出版信息

Ther Innov Regul Sci. 2024 Jan;58(1):136-142. doi: 10.1007/s43441-023-00577-3. Epub 2023 Oct 3.


DOI:10.1007/s43441-023-00577-3
PMID:37787890
Abstract

The accelerated approval (AA) program in the USA has succeeded in expediting the regulatory approval of new cancer drugs based on surrogate endpoint data. It is unclear whether the AA program promotes overall drug development, including verification of the clinical benefit, as the verification of drugs granted AA often takes long time. To determine the impact of the AA program on overall drug development, the time required for verification of clinical benefits was compared between anticancer drugs that initially received AA and those that received regular approval (RA). It was found that anticancer drugs that were approved under the AA program took longer time for verification, suggesting that the program may delay the start of a confirmatory study, and there may be room for speeding up the process. In addition, discordance was found in the pivotal study between the USA and the EU and the USA and Japan for obtaining the indication for which AA was granted in the USA and a delay in the start of the confirmatory study for the AA indication was considered to lead to a delay in approval in the EU and Japan. Early initiation of confirmatory studies for AA indications is recommended to reduce the time that patients receive drugs with unproven benefit in the USA, as well as to deliver innovative new drugs to patients earlier in the EU and Japan.

摘要

美国的加速审批(AA)计划成功地基于替代终点数据加快了新癌症药物的监管审批。尚不清楚 AA 计划是否促进了整体药物开发,包括对临床获益的验证,因为对获得 AA 的药物的验证往往需要很长时间。为了确定 AA 计划对整体药物开发的影响,比较了最初获得 AA 和常规批准(RA)的抗癌药物进行临床获益验证所需的时间。结果发现,根据 AA 计划获得批准的抗癌药物进行验证所需的时间更长,这表明该计划可能会延迟确证性研究的开始,并且可能有加快该过程的空间。此外,在美国、欧盟和日本之间,获得在美国获得 AA 批准的适应证的关键性研究存在差异,并且 AA 适应证的确证性研究的启动延迟被认为会导致在欧盟和日本的批准延迟。建议尽早启动 AA 适应证的确证性研究,以减少在美国接受未经证实获益的药物的患者的时间,并在欧盟和日本更早地为患者提供创新的新药。

相似文献

[1]
Impact of the US Accelerated Approval for New Anticancer Drugs on Time to Verification of Benefit and Regulatory Approval in the EU and Japan.

Ther Innov Regul Sci. 2024-1

[2]
Approval of Cancer Drugs With Uncertain Therapeutic Value: A Comparison of Regulatory Decisions in Europe and the United States.

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[3]
Characteristics of Clinical Trials for the US Food and Drug Administration Accelerated Approval and Subsequent Confirmatory Trials: Implications for Drug Approval in Japan.

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[4]
Characteristics of Anticancer Drugs Approved Under the Accelerated Approval Program in the US: Success or Failure in Converting to Regular Approval.

Ther Innov Regul Sci. 2024-3

[5]
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[6]
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[7]
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[8]
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[9]
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[10]
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引用本文的文献

[1]
Verifying Clinical Benefit of New Anticancer Drugs After Regulatory Approval Based on Exploratory Studies.

Ther Innov Regul Sci. 2025-5

[2]
Are We Losing the Final Fight against Cancer?

Cancers (Basel). 2024-1-19

本文引用的文献

[1]
The On- and Off-Ramps of Oncology Accelerated Approval.

N Engl J Med. 2022-10-20

[2]
"Dangling" Accelerated Approvals in Oncology.

N Engl J Med. 2021-5-6

[3]
Assessment of Coverage in England of Cancer Drugs Qualifying for US Food and Drug Administration Accelerated Approval.

JAMA Intern Med. 2021-4-1

[4]
Flexible and Expedited Regulatory Review Processes for Innovative Medicines and Regenerative Medical Products in the US, the EU, and Japan.

Int J Mol Sci. 2019-8-3

[5]
Estimation of Study Time Reduction Using Surrogate End Points Rather Than Overall Survival in Oncology Clinical Trials.

JAMA Intern Med. 2019-5-1

[6]
A 25-Year Experience of US Food and Drug Administration Accelerated Approval of Malignant Hematology and Oncology Drugs and Biologics: A Review.

JAMA Oncol. 2018-6-1

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