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Updated: Aug 13, 2026

A Real-time Potency Assay for Chimeric Antigen Receptor T Cells Targeting Solid and Hematological Cancer Cells
Published on: November 12, 2019
First CAR to Pass the Road Test: Tisagenlecleucel's Drive to FDA Approval
Mark B Geyer1,2
1Leukemia Service, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, New York. geyerm@mskcc.org.
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.
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