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# Breyanzi OK’d for Hard-to-Treat Marginal Zone Lymphoma
- URL: https://www.fdaweb.com/breyanzi-okd-for-hard-to-treat-marginal-zone-lymphoma/
- Published: 2025-12-05T12:00:00.000Z
- Updated: 2026-09-14T15:28:26.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5160337

FDA has approved Juno Therapeutics’ CAR-T therapy lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior systemic therapies. The decision gives patients with heavily pretreated MZL — a rare form of non-Hodgkin lymphoma — a new treatment option after conventional therapies stop working, an agency release says. Breyanzi, a CD19-directed CAR T cell therapy, was previously approved in the U.S. for several B-cell malignancies.

The approval is based on results from the TRANSCEND FL-MZL cohort, an open-label, multicenter Phase 2 study evaluating Breyanzi in adults whose disease returned after multiple therapies or following a stem-cell transplant. FDA says Breyanzi delivered an overall response rate of 84%, including a complete response rate of nearly 56%, according to independent review using Lugano criteria. Median duration of response had not yet been reached at the time of analysis, suggesting durable benefit for many responders.

The prescribing information will include boxed or heightened warnings for known CAR-T–associated toxicities, including:

- Cytokine release syndrome (CRS)
- Neurologic toxicities
- Serious infections
- Prolonged cytopenias
- Hypogammaglobulinemia
- Secondary malignancies
- Immune-effector–cell–associated hemophagocytic lymphohistiocytosis–like syndrome