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重新审视不可知论药物研发。

Agnostic drug development revisited.

机构信息

Department of Medical Oncology, Vall d́Hebron Barcelona Hospital Campus, Barcelona, Spain; Vall d́Hebron Institute of Oncology, Barcelona, Spain.

Vall d́Hebron Institute of Oncology, Barcelona, Spain.

出版信息

Cancer Treat Rev. 2024 Jul;128:102747. doi: 10.1016/j.ctrv.2024.102747. Epub 2024 Apr 27.

DOI:10.1016/j.ctrv.2024.102747
PMID:38763053
Abstract

The advent of molecular profiling and the generalization of next generation sequencing in oncology has enabled the identification of patients who could benefit from targeted agents. Since the tumor-agnostic approval of pembrolizumab for patients with MSI-High tumors in 2017, different molecularly-guided therapeutics have been awarded approvals and progressively incorporated in the treatment landscape across multiple tumor types. As the number of tumor-agnostic targets considered druggable expands in the clinic, novel challenges will reshape the drug development field involving all the stakeholders in oncology. In this review, we provide an overview of current tumor-agnostic approvals and discuss promising candidate therapeutics for tumor-agnostic designation and challenges for their broad implementation.

摘要

随着分子谱分析的出现和下一代测序在肿瘤学中的广泛应用,能够识别出可能从靶向药物中获益的患者。自 2017 年 MSI-High 肿瘤患者的 pembrolizumab 获得肿瘤不可知批准以来,不同的分子指导治疗方法已获得批准,并在多种肿瘤类型的治疗领域中逐步得到应用。随着临床上可考虑进行药物治疗的肿瘤不可知靶点数量的增加,新的挑战将重塑涉及肿瘤学所有利益相关者的药物开发领域。在这篇综述中,我们概述了目前的肿瘤不可知批准,并讨论了有前途的肿瘤不可知指定候选治疗药物及其广泛实施的挑战。

相似文献

1
Agnostic drug development revisited.重新审视不可知论药物研发。
Cancer Treat Rev. 2024 Jul;128:102747. doi: 10.1016/j.ctrv.2024.102747. Epub 2024 Apr 27.
2
Site-agnostic biomarker-guided oncology drug development.基于无靶点生物标志物的肿瘤药物研发。
Expert Rev Mol Diagn. 2020 Jun;20(6):583-592. doi: 10.1080/14737159.2020.1702521. Epub 2019 Dec 12.
3
Use of pembrolizumab among older adults with cancer in the United States, before and after FDA approval of its tumor-agnostic indication.在美国,FDA 批准 pembrolizumab 的肿瘤不可知适应证之前和之后,在老年癌症患者中的使用情况。
Pharmacoepidemiol Drug Saf. 2024 Jan;33(1):e5745. doi: 10.1002/pds.5745. Epub 2023 Dec 29.
4
Agnostic-Histology Approval of New Drugs in Oncology: Are We Already There?肿瘤学中对新药的不可知论组织学批准:我们是否已经达到了这一目标?
Clin Cancer Res. 2019 Jun 1;25(11):3210-3219. doi: 10.1158/1078-0432.CCR-18-3694. Epub 2019 Jan 22.
5
Tumor-type agnostic, targeted therapies make a new step forward: The first tumor-agnostic approval of a HER2-targeted therapy.肿瘤类型不可知的靶向治疗取得新进展:首个肿瘤不可知的 HER2 靶向治疗获批。
Biomol Biomed. 2024 Jul 28;24(4):673-675. doi: 10.17305/bb.2024.10641.
6
Developing Drugs for Tissue-Agnostic Indications: A Paradigm Shift in Leveraging Cancer Biology for Precision Medicine.开发针对组织非依赖性适应症的药物:利用癌症生物学实现精准医学的范式转变。
Clin Pharmacol Ther. 2021 Feb;109(2):334-342. doi: 10.1002/cpt.1946. Epub 2020 Jul 16.
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The evolving landscape of tissue-agnostic therapies in precision oncology.精准肿瘤学中组织不可知治疗方法的不断发展。
CA Cancer J Clin. 2024 Sep-Oct;74(5):433-452. doi: 10.3322/caac.21844. Epub 2024 May 30.
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The FDA Oncology Center of Excellence and precision medicine.美国食品和药物管理局肿瘤卓越中心与精准医学
Exp Biol Med (Maywood). 2018 Feb;243(3):308-312. doi: 10.1177/1535370217740861. Epub 2017 Nov 6.
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Agnostic Approvals in Oncology: Getting the Right Drug to the Right Patient with the Right Genomics.肿瘤学中的无偏见批准:通过正确的基因组学将正确的药物给予正确的患者。
Pharmaceuticals (Basel). 2023 Apr 19;16(4):614. doi: 10.3390/ph16040614.
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FDA Approvals of Oncology Drugs for Tissue-Agnostic Indications.FDA 批准用于组织不可知适应症的肿瘤药物。
Target Oncol. 2023 Sep;18(5):777-792. doi: 10.1007/s11523-023-00982-6. Epub 2023 Jul 21.

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