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首个通过道路测试的 CAR-T 细胞疗法：Tisagenlecleucel 获 FDA 批准。

First CAR to Pass the Road Test: Tisagenlecleucel's Drive to FDA Approval.

机构信息

Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.

Cellular Therapeutics Center, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York.

出版信息

Clin Cancer Res. 2019 Feb 15;25(4):1133-1135. doi: 10.1158/1078-0432.CCR-18-3328. Epub 2018 Nov 21.

DOI:10.1158/1078-0432.CCR-18-3328
PMID:30463849
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6377838/
Abstract

In August 2017, the FDA took historic action in granting the first approval of gene therapy to tisagenlecleucel. This landmark step brought CAR T-cell therapy to the commercial space and heralded a new era in managing refractory B-cell malignancies and FDA oversight of gene-modified therapies.See related article by O'Leary et al., p. 1142.

摘要

2017 年 8 月，FDA 采取了历史性的行动，批准了 tisagenlecleucel 的基因治疗的首次批准。这一里程碑式的步骤将 CAR T 细胞疗法带入了商业领域，并开创了管理难治性 B 细胞恶性肿瘤和 FDA 监管基因修饰疗法的新时代。见 O'Leary 等人的相关文章，第 1142 页。

相似文献

[1]
First CAR to Pass the Road Test: Tisagenlecleucel's Drive to FDA Approval.

Clin Cancer Res. 2018-11-21

[2]
FDA Approval Summary: Tisagenlecleucel for Treatment of Patients with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia.

Clin Cancer Res. 2018-10-11

[3]
Tisagenlecleucel-T for the treatment of acute lymphocytic leukemia.

Expert Opin Biol Ther. 2018-10-12

[4]
[Treatment of lymphoblastic leukemia with CD19-specific modified chimeric antigen receptor T cells].

Zhongguo Shi Yan Xue Ye Xue Za Zhi. 2014-12

[5]
CD19 CAR T Cells for the Treatment of Pediatric Pre-B Cell Acute Lymphoblastic Leukemia.

Paediatr Drugs. 2020-2

[6]
Tisagenlecleucel, an approved anti-CD19 chimeric antigen receptor T-cell therapy for the treatment of leukemia.

Drugs Today (Barc). 2017-11

[7]
Immunotherapy: CAR T cell therapy efficacious against B-ALL across age groups.

Nat Rev Clin Oncol. 2018-4

[8]
Improving outcomes and mitigating costs associated with CAR T-cell therapy.

Am J Manag Care. 2021-8

[9]
[CAR-T cells in acute lymphoblastic leukemias: What's new?].

Bull Cancer. 2020-2

[10]
CD19-Targeted chimeric antigen receptor-modified T-cell immunotherapy for B-cell malignancies.

Clin Pharmacol Ther. 2016-9

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[3]
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Front Immunol. 2022

[4]
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[5]
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[6]
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[7]
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[8]
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本文引用的文献

[1]
FDA Approval Summary: Tisagenlecleucel for Treatment of Patients with Relapsed or Refractory B-cell Precursor Acute Lymphoblastic Leukemia.

Clin Cancer Res. 2018-10-11

[2]
The Next Phase of Human Gene-Therapy Oversight.

N Engl J Med. 2018-10-11

[3]
Tisagenlecleucel in Children and Young Adults with B-Cell Lymphoblastic Leukemia.

N Engl J Med. 2018-2-1

[4]
Phase I/Phase II Study of Blinatumomab in Pediatric Patients With Relapsed/Refractory Acute Lymphoblastic Leukemia.

J Clin Oncol. 2016-10-31

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