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# BMS Files sBLA for Breyanzi Expanded Use
- URL: https://www.fdaweb.com/bms-files-sbla-for-breyanzi-expanded-use/
- Published: 2023-11-10T12:00:00.000Z
- Updated: 2026-09-14T14:15:52.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5155771

FDA has accepted for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel) to expand its current indication to include treating adult patients with relapsed or refractory chronic lymphocytic leukemia or small lymphocytic lymphoma who received a prior Bruton tyrosine kinase inhibitor and B-cell lymphoma 2 inhibitor. The agency has set a user fee review action target date of 3/14/2024.

Breyanzi is described as CD-19 directed CAR T cell therapy with a 4-1BB costimulatory domain. It is currently approved by FDA to treat large B-cell lymphoma, including certain patients with diffuse large B-cell lymphoma.