FDA approval of the first cellular therapy for a solid (non-hematologic) cancer.
作者信息
Kochenderfer James N
机构信息
Surgery Branch, National Cancer Institute, National Institutes of Health, Bethesda, MD, USA.
出版信息
Mol Ther. 2024 Apr 3;32(4):857-858. doi: 10.1016/j.ymthe.2024.03.012. Epub 2024 Mar 19.
Abstract
摘要
相似文献
1
FDA approval of the first cellular therapy for a solid (non-hematologic) cancer.美国食品药品监督管理局批准首款用于实体（非血液学）癌症的细胞疗法。
Mol Ther. 2024 Apr 3;32(4):857-858. doi: 10.1016/j.ymthe.2024.03.012. Epub 2024 Mar 19.
2
Clinical Trial Evidence Supporting US Food and Drug Administration Approval of Novel Cancer Therapies Between 2000 and 2016.2000 年至 2016 年间支持美国食品和药物管理局批准新型癌症疗法的临床试验证据。
JAMA Netw Open. 2020 Nov 2;3(11):e2024406. doi: 10.1001/jamanetworkopen.2020.24406.
3
Approved monoclonal antibodies for cancer therapy.已批准用于癌症治疗的单克隆抗体。
Expert Opin Biol Ther. 2008 Aug;8(8):1151-8. doi: 10.1517/14712598.8.8.1151.
4
Monthly and Median Costs of Cancer Drugs at the Time of FDA Approval 1965-2016.1965年至2016年美国食品药品监督管理局批准时癌症药物的月度成本和中位数成本。
J Natl Cancer Inst. 2017 Aug 1;109(8). doi: 10.1093/jnci/djx173.
5
FDA Approval of Tisagenlecleucel: Promise and Complexities of a $475 000 Cancer Drug.FDA批准tisagenlecleucel：一种售价47.5万美元的癌症药物的前景与复杂性
JAMA. 2017 Nov 21;318(19):1861-1862. doi: 10.1001/jama.2017.15218.
6
While We're at It, Let's Whack the FDA.既然说到这个，我们来抨击一下美国食品药品监督管理局吧。
Oncologist. 2016 Mar;21(3):259-60. doi: 10.1634/theoncologist.2016-0041. Epub 2016 Feb 11.
7
New Oncologic Drugs from 2008 to 2023-Differences in Approval and Access between the United States, Europe and Brazil.2008 年至 2023 年的新型肿瘤药物——美国、欧洲和巴西在审批和可及性方面的差异。
Curr Oncol. 2024 Aug 2;31(8):4443-4454. doi: 10.3390/curroncol31080332.
8
Cancer drugs remain FDA approved despite lack of benefit, study finds.研究发现，尽管抗癌药物并无益处，但仍获美国食品药品监督管理局批准。
BMJ. 2016 Dec 6;355:i6568. doi: 10.1136/bmj.i6568.
9
Selection bias, phase II trials, and the FDA accelerated approval process.
J Natl Cancer Inst. 2003 Sep 17;95(18):1351-2. doi: 10.1093/jnci/djg070.
10
2011 FDA drug approvals.2011年美国食品药品监督管理局批准的药物
Nat Rev Drug Discov. 2012 Feb 1;11(2):91-4. doi: 10.1038/nrd3657.
本文引用的文献
1
T cell receptor therapeutics: immunological targeting of the intracellular cancer proteome.T 细胞受体疗法：细胞内癌症蛋白质组的免疫靶向治疗。
Nat Rev Drug Discov. 2023 Dec;22(12):996-1017. doi: 10.1038/s41573-023-00809-z. Epub 2023 Oct 27.
2
Efficacy and safety of lifileucel, a one-time autologous tumor-infiltrating lymphocyte (TIL) cell therapy, in patients with advanced melanoma after progression on immune checkpoint inhibitors and targeted therapies: pooled analysis of consecutive cohorts of the C-144-01 study.在免疫检查点抑制剂和靶向治疗进展后，晚期黑色素瘤患者单次自体肿瘤浸润淋巴细胞（TIL）细胞治疗 lifileucel 的疗效和安全性：C-144-01 研究连续队列的汇总分析。
J Immunother Cancer. 2022 Dec;10(12). doi: 10.1136/jitc-2022-005755.
3
Lifileucel, a Tumor-Infiltrating Lymphocyte Therapy, in Metastatic Melanoma.利弗利塞（一种肿瘤浸润淋巴细胞疗法）治疗转移性黑色素瘤。
J Clin Oncol. 2021 Aug 20;39(24):2656-2666. doi: 10.1200/JCO.21.00612. Epub 2021 May 12.
4
Cancer immunotherapy based on mutation-specific CD4+ T cells in a patient with epithelial cancer.基于突变特异性 CD4+T 细胞的癌症免疫疗法在一名上皮癌患者中的应用。
Science. 2014 May 9;344(6184):641-5. doi: 10.1126/science.1251102.
5
Cancer regression and autoimmunity in patients after clonal repopulation with antitumor lymphocytes.抗肿瘤淋巴细胞克隆性再增殖后患者的癌症消退与自身免疫
Science. 2002 Oct 25;298(5594):850-4. doi: 10.1126/science.1076514. Epub 2002 Sep 19.
6
7
A new approach to the adoptive immunotherapy of cancer with tumor-infiltrating lymphocytes.一种采用肿瘤浸润淋巴细胞进行癌症过继性免疫治疗的新方法。
Science. 1986 Sep 19;233(4770):1318-21. doi: 10.1126/science.3489291.
8
Interleukin 2 activation of cytotoxic T-lymphocytes infiltrating into human metastatic melanomas.白细胞介素2对浸润入人转移性黑色素瘤的细胞毒性T淋巴细胞的激活作用。
Cancer Res. 1986 Jun;46(6):3011-7.
9
Immunotherapy of patients with advanced cancer using tumor-infiltrating lymphocytes and recombinant interleukin-2: a pilot study.使用肿瘤浸润淋巴细胞和重组白细胞介素-2对晚期癌症患者进行免疫治疗：一项试点研究。
J Clin Oncol. 1988 May;6(5):839-53. doi: 10.1200/JCO.1988.6.5.839.
Zotero 插件