First CAR to Pass the Road Test: Tisagenlecleucel's Drive to FDA Approval.
editorial · Level V
Where this comes from
- Record sourced from PubMed, PMID 30463849.
- Also identified by DOI 10.1158/1078-0432.CCR-18-3328 and PMC identifier 6377838.
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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.
Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
- Receptors, Antigen, T-Cell