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

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 re...

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Bibliographic Details
Published in:Clinical cancer research 2019-02, Vol.25 (4), p.1133-1135
Main Author: Geyer, Mark B
Format: Article
Language:English
Subjects:
B-Lymphocytes
Humans
Immunotherapy, Adoptive
Precursor Cell Lymphoblastic Leukemia-Lymphoma
Receptors, Antigen, T-Cell
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Summary: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.
ISSN:1078-0432
1557-3265
DOI:10.1158/1078-0432.CCR-18-3328