On December 4, 2025, the US Food and Drug Administration (FDA) approved the CD19/CD3-directed CAR T-cell therapy lisocabtagene maraleucel (Breyanzi) for adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received ≥2 prior lines of systemic therapy.

The approval was supported by the MZL cohort of the open-label, multicenter, single-arm phase 2 TRANSCEND FL trial (NCT04245839). A total of 77 patients underwent leukapheresis, and 66 treated patients comprised the primary efficacy analysis set. Patients received a single lisocabtagene maraleucel infusion 2–7 days after lymphodepleting chemotherapy.

The primary endpoint was overall response rate (ORR), assessed per Lugano criteria by an independent review committee. In the intention-to-treat population, the ORR was 84.4% (95% CI, 74.4%–91.7%), including a 55.8% complete response rate (95% CI, 44.1%–67.2%). Median duration of response had not been reached at the time of analysis.

The safety profile reflected the known adverse-event spectrum of lisocabtagene maraleucel. The prescribing information contains boxed warnings for cytokine release syndrome (CRS) and neurologic toxicities. Additional risks include hypogammaglobulinemia, serious infections, prolonged cytopenias, secondary malignancies, and immune-effector-cell–associated hemophagocytic lymphohistiocytosis–like syndrome.

References:

US Food and Drug Administration. FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma. Published December 4, 2025. Accessed December 6, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma