• 文献检索
  • 文档翻译
  • 深度研究
  • 学术资讯
  • Suppr Zotero 插件Zotero 插件
  • 邀请有礼
  • 套餐&价格
  • 历史记录
应用&插件
Suppr Zotero 插件Zotero 插件浏览器插件Mac 客户端Windows 客户端微信小程序
定价
高级版会员购买积分包购买API积分包
服务
文献检索文档翻译深度研究API 文档MCP 服务
关于我们
关于 Suppr公司介绍联系我们用户协议隐私条款
关注我们

Suppr 超能文献

核心技术专利：CN118964589B侵权必究
粤ICP备2023148730 号-1Suppr @ 2026

文献检索

告别复杂PubMed语法，用中文像聊天一样搜索，搜遍4000万医学文献。AI智能推荐，让科研检索更轻松。

立即免费搜索

文件翻译

保留排版，准确专业，支持PDF/Word/PPT等文件格式，支持 12+语言互译。

免费翻译文档

深度研究

AI帮你快速写综述，25分钟生成高质量综述，智能提取关键信息，辅助科研写作。

立即免费体验

相似文献

1
Oncology Accelerated Approval Confirmatory Trials: When a Failed Trial Is Not a Failed Drug.肿瘤学加速批准确证性试验：当试验失败时，药物未必失败。
J Clin Oncol. 2024 Nov 10;42(32):3778-3782. doi: 10.1200/JCO-24-01654. Epub 2024 Oct 9.
2
Characterization of accelerated approval status, trial endpoints and results, and recommendations in guidelines for oncology drug treatments from the National Comprehensive Cancer Network: cross sectional study.美国国立综合癌症网络肿瘤药物治疗指南中加速批准状态、试验终点与结果及建议的特征：横断面研究
BMJ Med. 2024 Apr 5;3(1):e000802. doi: 10.1136/bmjmed-2023-000802. eCollection 2024.
3
US Food and Drug Administration Accelerated Approval Program for Nononcology Drug Indications Between 1992 and 2018.美国食品和药物管理局在 1992 年至 2018 年间对非肿瘤药物适应症的加速审批计划。
JAMA Netw Open. 2022 Sep 1;5(9):e2230973. doi: 10.1001/jamanetworkopen.2022.30973.
4
A comparison of the Food and Drug Administration's and Health Canada's regulatory decisions about failed confirmatory trials for oncology drugs: an observational study.美国食品药品监督管理局与加拿大卫生部针对肿瘤药物确证性试验失败所做监管决策的比较：一项观察性研究
J Pharm Policy Pract. 2021 Oct 28;14(1):93. doi: 10.1186/s40545-021-00375-y.
5
Factors in Time to Full Approval or Withdrawal for Anticancer Medicines Granted Accelerated Approval by the FDA.美国食品药品监督管理局（FDA）加速批准的抗癌药物完全获批或撤回所需时间的影响因素。
JAMA Netw Open. 2025 Mar 3;8(3):e252026. doi: 10.1001/jamanetworkopen.2025.2026.
6
Assessment of the Clinical Benefit of Cancer Drugs Receiving Accelerated Approval.加速批准的癌症药物的临床获益评估。
JAMA Intern Med. 2019 Jul 1;179(7):906-913. doi: 10.1001/jamainternmed.2019.0462.
7
Characteristics of Preapproval and Postapproval Studies for Drugs Granted Accelerated Approval by the US Food and Drug Administration.美国食品药品监督管理局批准加速批准的药物的批准前和批准后研究特征。
JAMA. 2017 Aug 15;318(7):626-636. doi: 10.1001/jama.2017.9415.
8
Accelerated approval of oncology products: the food and drug administration experience.肿瘤学产品的加速审批：美国食品和药物管理局的经验。
J Natl Cancer Inst. 2011 Apr 20;103(8):636-44. doi: 10.1093/jnci/djr062. Epub 2011 Mar 21.
9
Accelerated approval of cancer drugs: improved access to therapeutic breakthroughs or early release of unsafe and ineffective drugs?癌症药物的加速批准：是改善了对治疗突破的获取，还是过早放行不安全且无效的药物？
J Clin Oncol. 2009 Sep 10;27(26):4398-405. doi: 10.1200/JCO.2008.21.1961. Epub 2009 Jul 27.
10
Characteristics of Anticancer Drugs Approved Under the Accelerated Approval Program in the US: Success or Failure in Converting to Regular Approval.美国加速批准程序下批准的抗癌药物的特点：转换为常规批准的成败。
Ther Innov Regul Sci. 2024 Mar;58(2):387-394. doi: 10.1007/s43441-023-00607-0. Epub 2024 Jan 4.

引用本文的文献

1
Factors in Time to Full Approval or Withdrawal for Anticancer Medicines Granted Accelerated Approval by the FDA.美国食品药品监督管理局（FDA）加速批准的抗癌药物完全获批或撤回所需时间的影响因素。
JAMA Netw Open. 2025 Mar 3;8(3):e252026. doi: 10.1001/jamanetworkopen.2025.2026.
2
The clinical journey of belantamab mafodotin in relapsed or refractory multiple myeloma: lessons in drug development.贝兰他单抗莫福汀治疗复发或难治性多发性骨髓瘤的临床历程：药物研发经验教训
Blood Cancer J. 2025 Feb 7;15(1):15. doi: 10.1038/s41408-025-01212-0.

本文引用的文献

1
The On- and Off-Ramps of Oncology Accelerated Approval.肿瘤学加速批准的“入口匝道”与“出口匝道”
N Engl J Med. 2022 Oct 20;387(16):1439-1442. doi: 10.1056/NEJMp2208954. Epub 2022 Sep 21.
2
Immunotherapy for Patients With Small-Cell Lung Cancer-2 Gains, 2 Losses.小细胞肺癌患者的免疫疗法2项进展，2项不足。
JAMA Oncol. 2022 Jan 1;8(1):37-38. doi: 10.1001/jamaoncol.2021.4956.
3
The Drug-Dosing Conundrum in Oncology - When Less Is More.肿瘤学中的给药难题——少即是多。
N Engl J Med. 2021 Oct 14;385(16):1445-1447. doi: 10.1056/NEJMp2109826. Epub 2021 Oct 9.
4
"Dangling" Accelerated Approvals in Oncology.肿瘤学中的“悬空”加速批准
N Engl J Med. 2021 May 6;384(18):e68. doi: 10.1056/NEJMp2104846. Epub 2021 Apr 21.
5
FDA Approval of Gefitinib for the Treatment of Patients with Metastatic EGFR Mutation-Positive Non-Small Cell Lung Cancer.吉非替尼获美国食品药品监督管理局批准用于治疗转移性表皮生长因子受体（EGFR）突变阳性的非小细胞肺癌患者。
Clin Cancer Res. 2016 Mar 15;22(6):1307-12. doi: 10.1158/1078-0432.CCR-15-2266.

Oncology Accelerated Approval Confirmatory Trials: When a Failed Trial Is Not a Failed Drug.

作者信息

Mehta Gautam U, Pazdur Richard

机构信息

Oncology Center of Excellence, Food and Drug Administration, Silver Spring, MD.

出版信息

J Clin Oncol. 2024 Nov 10;42(32):3778-3782. doi: 10.1200/JCO-24-01654. Epub 2024 Oct 9.

DOI:10.1200/JCO-24-01654
PMID:39383488
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11540715/
Abstract
摘要