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

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

Mark B Geyer  1   2
Affiliations
Comment

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

Mark B Geyer. Clin Cancer Res. .

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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Conflict of interest statement

Disclosure of potential conflicts of interest: Geyer: Dava Oncology (honorarium)

Figures

Figure 1:
Figure 1:
Workflow for tisagenlecleucel and other CAR T-cell therapies becoming commercially available. Safe and successful delivery of tisagenlecleucel therapy requires considerable institutional engagement (skilled intake team, leukapheresis team, appropriately trained nursing and medical staff, pharmacy staff, and reporting/regulatory compliance), manufacturing facilities equipped to meet commercial product needs, and continued, conscientious FDA oversight.
See this image and copyright information in PMC

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References

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