On December 4, 2025, the Food and Drug Administration approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics, Inc., 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.

Full prescribing information for Breyanzi will be posted here.

Efficacy was evaluated in the TRANSCEND FL-MZL Cohort (NCT04245839), an open-label, multicenter, single-arm trial in adults with relapsed or refractory MZL who had received at least two or more lines of systemic therapy or who relapsed after hematopoietic stem cell transplant (HSCT). The trial included patients with an ECOG performance of 1 or less.

Patients received a single dose of lisocabtagene maraleucel two to seven days following the completion of lymphodepleting chemotherapy (fludarabine 30 mg/m2/day and cyclophosphamide 300 mg/m2/day concurrently for three days). The efficacy analyses were performed in 77 leukapheresed patients (the intention-to-treat, ITT, population) and in 66 treated patients who had confirmed measurable disease by computed tomography (CT) scan at baseline, received conforming product in intended dose range and had at least 9 months of follow up from the date of first response.

The main efficacy outcome measure was overall response rate (ORR), defined as the percentage of patients with the best overall response (BOR) of complete response (CR) or partial response (PR) per Lugano criteria, and duration of response (DOR) as determined by an independent review committee (IRC). The ORR in ITT population was 84.4% (95% CI: 74.4, 91.7) and the CRR was 55.8% (95% CI: 44.1, 67.2). The median DOR was not reached (NR) (95% CI: 25.59, NR).

The prescribing information includes warnings and precautions for cytokine release syndrome (CRS), neurologic toxicities, hypersensitivity reactions, serious infections, prolonged cytopenias, hypogammaglobulinemia, secondary malignancies, and immune effector-cell-associated hemophagocytic lymphohistiocytosis-like syndrome.

The recommended lisocabtagene maraleucel dose is 90 to 110 × 106 CAR-positive viable T cells with a 1:1 ratio of CD4 and CD8 components.

This review used the Assessment Aid, a voluntary submission from the applicant to facilitate the FDA’s assessment.

This application was granted priority review. Lisocabtagene maraleucel received orphan drug designation. FDA expedited programs are described in the Guidance for Industry: Expedited Programs for Serious Conditions-Drugs and Biologics. A description of FDA expedited programs for regenerative medicine advanced therapies is in the Guidance for Industry: Expedited Programs for Regenerative Medicine Therapies for Serious Conditions.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

For assistance with single-patient INDs for investigational oncology products regulated by the Center for Biologics Evaluation and Research, healthcare professionals may email OTPRPMS@fda.hhs.gov.

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