FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma

Regulatory approval: On Dec 4, 2025, the FDA approved lisocabtagene maraleucel (Breyanzi) for adults with relapsed or refractory marginal zone lymphoma (MZL) after at least two prior lines of systemic therapy. Approval was supported by the single-arm, open-label TRANSCEND FL-MZL Cohort (NCT04245839). In the intention-to-treat population (n=77 leukapheresed), ORR was 84.4% and CRR 55.8%; median duration of response was not reached.

FDA approval: lisocabtagene maraleucel in relapsed/refractory MZL (Dec 4, 2025)

Type: Regulatory approval

On December 4, 2025, the FDA approved lisocabtagene maraleucel (Breyanzi; Juno Therapeutics, a Bristol-Myers Squibb Company) for adults with relapsed or refractory marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy.

Supporting evidence

Efficacy was evaluated in the TRANSCEND FL-MZL Cohort (NCT04245839), an open-label, multicenter, single-arm trial enrolling adults with relapsed/refractory MZL who had received ≥2 lines of systemic therapy or relapsed after hematopoietic stem cell transplant (HSCT). Eligible patients had ECOG performance status ≤1.

Patients received a single dose of lisocabtagene maraleucel 2–7 days after lymphodepleting chemotherapy with fludarabine 30 mg/m²/day and cyclophosphamide 300 mg/m²/day for 3 days.

Primary outcomes were overall response rate (ORR) and duration of response (DOR) per Lugano criteria, assessed by an independent review committee.

  • ITT population: 77 leukapheresed patients; ORR 84.4% (95% CI, 74.4–91.7); CRR 55.8% (95% CI, 44.1–67.2)
  • Median DOR: not reached (95% CI, 25.59–NR)

Label safety and dosing

Prescribing information includes warnings/precautions for CRS, neurologic toxicities, serious infections, prolonged cytopenias, hypogammaglobulinemia, secondary malignancies, and immune effector-cell–associated HLH-like syndrome, among others. Recommended dose: 90–110 × 10^6 CAR-positive viable T cells with a 1:1 CD4:CD8 ratio.

The application received priority review and orphan drug designation.

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