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# BMS BLA for B-cell Lymphoma Therapy
- URL: https://www.fdaweb.com/bms-bla-for-b-cell-lymphoma-therapy/
- Published: 2020-02-13T12:00:00.000Z
- Updated: 2026-09-14T16:03:01.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5146089

FDA has accepted for priority review a Bristol-Myers Squibb BLA for lisocabtagene maraleucel, an autologous anti-CD19 chimeric antigen receptor (CAR) T-cell immunotherapy with a defined composition of purified CD8+ and CD4+ CAR T cells for treating adult patients with relapsed or refractory large B-cell lymphoma after at least two prior therapies. The agency has set a user fee review target action date of 8/17\. The submission is based on safety and efficacy results from the TRANSCEND NHL 001 trial, evaluating lisocabtagene maraleucel in 268 patients large B-cell lymphoma. Lisocabtagene maraleucel was previously granted breakthrough therapy and regenerative medicine advanced therapy designations by FDA.