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# FDA Extends Review of BMS CAR T-cell Therapy
- URL: https://www.fdaweb.com/fda-extends-review-of-bms-car-t-cell-therapy/
- Published: 2020-05-06T12:00:00.000Z
- Updated: 2026-09-14T16:13:56.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5146732

FDA has extended by three months its review of a Bristol Myers Squibb BLA for lisocabtagene maraleucel (liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy for treating adults with relapsed or refractory large B-cell lymphoma after at least two prior therapies. After the BLA was submitted and at FDA’s request, the company submitted additional information that constituted a major amendment and additional review time. (XXX DELETE XXX)The new user fee review action date is 11/16.

Liso-cel aims to “target CD19-expressing cells through a CAR construct that includes an anti-CD19 single-chain variable fragment targeting domain for antigen specificity, a transmembrane domain, a 4-1BB costimulatory domain hypothesized to increase T-cell proliferation and persistence, and a CD3-zeta T-cell activation domain,” the company says. “The defined composition of CAR-positive viable T-cells (consisting of CD8 and CD4 components) in liso-cel may reduce product variability; however, the clinical significance of defined composition is unknown.”