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# BMS Files Breyanzi Marginal Zone Lymphoma sBLA
- URL: https://www.fdaweb.com/bms-files-breyanzi-marginal-zone-lymphoma-sbla/
- Published: 2025-08-06T12:00:00.000Z
- Updated: 2026-09-14T15:18:25.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5159637

FDA has accepted for priority review a Bristol Myers Squibb supplemental BLA for Breyanzi (lisocabtagene maraleucel; liso-cel) as a potential treatment for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. The agency has set a user fee review action target date of 12/5\. Breyanzi, a CD19-directed CAR T cell therapy, is currently approved in the U.S. for several B-cell malignancies.

The new application is based on data from the MZL cohort of the Phase 2 TRANSCEND FL trial, which showed promising efficacy and safety results, according to the company. The open-label study is evaluating Breyanzi in relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary endpoint is overall response rate, with secondary measures including complete response, duration of response, and progression-free survival.

“While initial therapy for MZL can be effective, multiple relapses over the course of several years are common,” the company says. “This FDA acceptance brings us one step closer to potentially standardizing CAR T cell therapy as a treatment option for MZL.”

MZL is the third most common form of non-Hodgkin lymphoma, representing about 7% of all cases, it says. The disease is typically slow-growing but prone to relapse, often requiring multiple lines of therapy over time. Transformation into a more aggressive lymphoma, such as diffuse large B-cell lymphoma, can also occur, it adds.