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# BMS Breyanzi ‘Deep and Durable Efficacy’
- URL: https://www.fdaweb.com/bms-breyanzi-deep-and-durable-efficacy/
- Published: 2023-05-26T12:00:00.000Z
- Updated: 2026-09-14T18:34:48.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154551

Bristol Myers Squibb says its Breyanzi (lisocabtagene maraleucel) showed “deep and durable efficacy” in the Phase 1/2 TRANSCEND CLL 004 study of adults with relapsed or refractory lymphocytic leukemia or small lymphocytic lymphoma. A company [statement](https://news.bms.com/news/corporate-financial/2023/Bristol-Myers-Squibbs-Breyanzi-lisocabtagene-maraleucel-is-First-and-Only-CAR-T-to-Deliver-Deep-and-Durable-Efficacy-in-Pivotal-Multicenter-Trial-in-Relapsed-or-Refractory-Chronic-Lymphocytic-Leukemia-Based-on-Data-Presented-at-ASCO-2023/default.aspx?ref=fdaweb.com) says Breyanzi delivered statistically significant complete response rates, the primary endpoint, in 18.4% of patients in the primary efficacy analysis. Among patients who achieved a complete response, it says, no disease progression or deaths were observed, with the median duration of response not reached.

Breyanzi is described as CD-19 directed CAR T cell therapy with a 4-1BB costimulatory domain. It is approved by FDA to treat large B-cell lymphoma, including certain patients with diffuse large B-cell lymphoma. It is not indicated to treat patients with primary central nervous system lymphoma.