FDA Approves Liso-Cel in Pretreated R/R Marginal Zone Lymphoma

The FDA has approved lisocabtagene maraleucel (liso-cel; Breyanzi) for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least 2 prior lines of therapy.¹

The approval is supported by data from the open-label, multicenter, single-arm phase 2 TRANSCEND FL trial (NCT04245839), which evaluated the use of liso-cel in patients with R/R MZL who had received 2 or more lines of prior therapy following hematopoietic stem cell transplant (HSCT), including patients with an ECOG performance status score of 1 or less.

The overall response rate (ORR) in the intent-to-treat population was 84.4% (95% CI, 74.4%-91.7%), and the complete response rate (CRR) was 55.8% (95% CI, 44.1%-67.2%). Median duration of response was not reached (NR; 95% CI, 25.59 months-NR).¹

ORR, the primary efficacy outcome measured, was defined as the percentage of patients with the best overall response of CR or partial response, per an independent review committee.¹

Liso-cel is recommended at a dose of 90 to 110 x 10⁶ chimeric antigen receptor–positive T cells with a 1:1 ratio of CD4 and CD8 components.¹

Safety of Liso-Cel in MZL

Bristol Myers Squibb, the developer of liso-cel, shared in a news release in February 2025 that the TRANSCEND FL trial had met its primary end point of ORR in its MZL cohort and its secondary end point of CRR. According to this statement, liso-cel demonstrated a safety profile consistent with prior findings.²

In a presentation during the 9th Annual School of Nursing Oncology, an event hosted by Physicians’ Education Resource®, LLC (PER®), Beth Faiman, PhD, MSN, APN-BC, BMTCN, AOCN, FAAN, FAPO, a nurse practitioner in the Department of Hematology and Medical Oncology at Cleveland Clinic in Ohio, said that T-cell engagers often can induce cytokine release syndrome (CRS) across disease states.³

“What we’re doing is taking the marker target on the cell—for example, CD20—and then CD3, like a helping hand, will bring it together and cause cell death when you’re directing these T cells,” Falman said. ”That causes a cytokine storm and a whole host of problems.…[CRS] and neurotoxicity syndrome are constants, regardless of the disease state.”

Further, Lauren Sheehan, MS, MSPAS, PA-C, a physician assistant at Atrium Levine Cancer Center in Charlotte, North Carolina, provided guidance on the management of adverse events common to liso-cel, including CRS, neurotoxicities, serious infection, prolonged cytopenias, hypogammaglobulinemia, and secondary T-cell malignancies in an exclusive guide to the use of liso-cel in mantle cell lymphoma (MCL) with Oncology Nursing News.

The FDA initially had a Risk Evaluation and Mitigation Strategy in place to monitor and mitigate certain safety events in patients receiving liso-cel and idecabtagene vicleucel (Abecma). However, these guidelines were removed in June 2025, with the FDA reducing driving restrictions for patients from 8 weeks to 2 weeks after treatment.⁴

Liso-Cel Approvals for Other Indications

Liso-cel was approved in May 2024 for use in previously treated R/R follicular lymphoma, also based on findings from the TRANSCEND FL trial, and later that same month for the treatment of adult patients with R/R MCL who have received 2 or more prior lines of therapy, including a Bruton tyrosine kinase inhibitor.^5,6

It was previously approved by the FDA in June 2022 for the second-line treatment of adult patients with R/R large B-cell lymphoma with primary refractory or early relapse within 12 months of frontline treatment, including those ineligible for HSCT.⁷

References

1. FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma. FDA. Updated December 4, 2025. Accessed December 4, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-lisocabtagene-maraleucel-relapsed-or-refractory-marginal-zone-lymphoma
2. Bristol Myers Squibb announces positive topline results for Breyanzi (lisocabtagene maraleucel) in adult patients with relapsed or refractory marginal zone lymphoma. News release. Bristol Myers Squibb. February 10, 2025. Accessed December 4, 2025. https://news.bms.com/news/corporate-financial/2025/Bristol-Myers-Squibb-Announces-Positive-Topline-Results-for-Breyanzi-lisocabtagene-maraleucel-in-Adult-Patients-with-Relapsed-or-Refractory-Marginal-Zone-Lymphoma/default.aspx
3. Faiman B. Updates in novel therapies across hematologic malignancies. Presented at: 9^th Annual School of Nursing Oncology; August 9, 2025; Nashville, TN.
4. U.S. Food and Drug Administration approves streamlined patient monitoring requirements and removal of REMS programs within Bristol Myers Squibb’s cell therapy labels. News release. Bristol Myers Squibb. June 26, 2025. Accessed December 4, 2025. https://news.bms.com/news/corporate-financial/2025/U-S--Food-and-Drug-Administration-Approves-Streamlined-Patient-Monitoring-Requirements-and-Removal-of-REMS-Programs-within-Bristol-Myers-Squibbs-Cell-Therapy-Labels/default.aspx
5. FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma. News release. FDA. May 15, 2024. Accessed February 5, 2026. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lisocabtagene-maraleucel-follicular-lymphoma
6. U.S. Food and Drug Administration Approves Bristol Myers Squibb’s Breyanzi as a New CAR T Cell Therapy for Relapsed or Refractory Mantle Cell Lymphoma. News release. Bristol Myers Squibb. May 30, 2024. Accessed February 5, 2026. https://news.bms.com/news/corporate-financial/2024/U.S.-Food-and-Drug-Administration-Approves-Bristol-Myers-Squibbs-Breyanzi-as-a-New-CAR-T-Cell-Therapy-for-Relapsed-or-Refractory-Mantle-Cell-Lymphoma/default.aspx
7. US FDA approves Bristol Myers Squibb’s CAR T cell therapy breyanzi for relapsed or refractory large B-cell lymphoma after one prior therapy. News release. Bristol Myers Squibb. June 24, 2022. Accessed February 5, 2026. https://bit.ly/3bvEXUF