• 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

Accelerated approvals hit the target in precision oncology.

作者信息

Subbiah Vivek, Wirth Lori J, Kurzrock Razelle, Pazdur Richard, Beaver Julia A, Singh Harpreet, Mehta Gautam U

机构信息

The University of Texas MD Anderson Cancer Center, Houston, TX, USA.

Harvard Medical School, Massachusetts General Hospital, Boston, MA, USA.

出版信息

Nat Med. 2022 Oct;28(10):1976-1979. doi: 10.1038/s41591-022-01984-z.

DOI:10.1038/s41591-022-01984-z
PMID:36192554
Abstract
摘要

相似文献

1
Accelerated approvals hit the target in precision oncology.加速批准在精准肿瘤学领域命中目标。
Nat Med. 2022 Oct;28(10):1976-1979. doi: 10.1038/s41591-022-01984-z.
2
Loose Regulatory Standards Portend a New Era of Imprecision Oncology.宽松的监管标准预示着精准肿瘤学的新时代到来。
Cancer Invest. 2021 Feb;39(2):120-123. doi: 10.1080/07357907.2020.1851705. Epub 2021 Jan 7.
3
Oncology's trial and error: Analysis of the FDA withdrawn accelerated approvals.肿瘤学的反复试验：FDA 撤回加速批准的分析。
Life Sci. 2024 Jun 1;346:122615. doi: 10.1016/j.lfs.2024.122615. Epub 2024 Apr 4.
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
Premarket Evidence and Postmarketing Requirements for Real-Time Oncology Review Indication Approvals.实时肿瘤学审查适应症批准的上市前证据和上市后要求。
JAMA Netw Open. 2024 May 1;7(5):e249233. doi: 10.1001/jamanetworkopen.2024.9233.
6
Cancer drugs speed to accelerated approvals, then hit the brakes in timely, clinically beneficial confirmatory trials.癌症药物迅速获得加速批准，然后在及时、具有临床益处的验证性试验中受阻。
Am J Manag Care. 2024 Aug;30(9 Spec No.):SP722-SP724. doi: 10.37765/ajmc.2024.89597.
7
Use of multiple endpoints and approval paths depicts a decade of FDA oncology drug approvals.多终点和审批途径的使用描绘了 FDA 肿瘤药物批准的十年历程。
Clin Cancer Res. 2013 Jul 15;19(14):3722-31. doi: 10.1158/1078-0432.CCR-13-0316. Epub 2013 May 10.
8
Oncology update.肿瘤学最新进展。
Oncol Nurs Forum. 2011 Jul;38(4):485-6. doi: 10.1188/11.ONF.485-486.
9
Making precision oncology the standard of care.使精准肿瘤学成为护理标准。
Lancet Oncol. 2017 Jul;18(7):835. doi: 10.1016/S1470-2045(17)30474-6.
10
Letter to the Editor: Re: "Life Years Gained From the FDA Accelerated Approval Program in Oncology: A Portfolio Model".致编辑的信：关于《从美国食品药品监督管理局肿瘤加速批准计划中获得的生命年：一种投资组合模型》
J Natl Compr Canc Netw. 2024 Sep;22(7). doi: 10.6004/jnccn.2024.7043.

引用本文的文献

1
Predictors of withdrawal of anticancer drug indications granted accelerated approval: a retrospective cohort study.获批加速批准的抗癌药物适应症撤销的预测因素：一项回顾性队列研究。
EClinicalMedicine. 2025 May 31;84:103088. doi: 10.1016/j.eclinm.2025.103088. eCollection 2025 Jun.
2
Surrogate end points in oncology: aligning drug development incentives and patient needs.肿瘤学中的替代终点：协调药物研发激励措施与患者需求。
Nat Rev Clin Oncol. 2025 Jun 6. doi: 10.1038/s41571-025-01031-z.
3
Cancer treatment paradigms in the precision medicine era.
精准医学时代的癌症治疗模式。
Nat Med. 2025 May 20. doi: 10.1038/s41591-025-03711-w.
4
Transforming paediatric AML trials: from failing one-size-fits-all methods to precision oncology.变革儿科急性髓系白血病试验：从失败的一刀切方法到精准肿瘤学
Nat Rev Clin Oncol. 2025 Mar;22(3):155-156. doi: 10.1038/s41571-025-00989-0.
5
The Utilization of the Accelerated Approval Pathway in Oncology: A Case Study of Pembrolizumab.肿瘤学中加速批准途径的应用：帕博利珠单抗的案例研究
Drugs. 2024 Dec;84(12):1579-1601. doi: 10.1007/s40265-024-02111-7. Epub 2024 Nov 13.
6
FDA approval summary: fam-trastuzumab deruxtecan-nxki for unresectable or metastatic non-small cell lung cancer with activating HER2 mutations.FDA 批准摘要：fam-trastuzumab deruxtecan-nxki 用于不可切除或转移性非小细胞肺癌伴激活的 HER2 突变。
Oncologist. 2024 Aug 5;29(8):667-671. doi: 10.1093/oncolo/oyae151.
7
Towards a coordinated approach for managing accelerated patient access to potentially beneficial medicines: reporting the perspectives of a multi-stakeholder, international workshop.迈向协调管理加速患者获取潜在有益药物的方法：报告多利益相关方国际研讨会的观点
Health Aff Sch. 2024 May 22;2(6):qxae069. doi: 10.1093/haschl/qxae069. eCollection 2024 Jun.
8
Impact of Early Access Reform on Oncology Innovation in France: Approvals, Patients, and Costs.早期准入改革对法国肿瘤学创新的影响：批准、患者和成本。
BioDrugs. 2024 May;38(3):465-475. doi: 10.1007/s40259-024-00658-1. Epub 2024 Apr 20.
9
If it's a target, it's a pan-cancer target: Tissue is not the issue.如果是靶点，那就是泛癌靶点：组织不是问题。
Cancer Treat Rev. 2024 Apr;125:102721. doi: 10.1016/j.ctrv.2024.102721. Epub 2024 Mar 21.
10
Association of Timely Comprehensive Genomic Profiling With Precision Oncology Treatment Use and Patient Outcomes in Advanced Non-Small-Cell Lung Cancer.及时全面的基因组分析与晚期非小细胞肺癌精准肿瘤治疗应用和患者结局的关联。
JCO Precis Oncol. 2024 Mar;8:e2300292. doi: 10.1200/PO.23.00292.