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

被引：16

作者：

Geyer, Mark B. ^{[1
,2
]}

机构：

[1] Mem Sloan Kettering Canc Ctr, Dept Med, Leukemia Serv, 1275 York Ave, New York, NY 10021 USA

[2] Mem Sloan Kettering Canc Ctr, Dept Med, Cellular Therapeut Ctr, 1275 York Ave, New York, NY 10021 USA

来源：

CLINICAL CANCER RESEARCH | 2019年 / 25卷 / 04期

关键词：

D O I：

10.1158/1078-0432.CCR-18-3328

中图分类号：

R73 [肿瘤学];

学科分类号：

100214 ;

摘要：

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.

引用

页码：1133 / 1135

页数：3

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