U.S. FDA Approves Liso-cel (Breyanzi) for Marginal Zone Lymphoma

On December 4, 2025, the U.S. Food and Drug Administration (FDA) approved lisocabtagene maraleucel (Breyanzi, Juno Therapeutics/Bristol Myers Squibb) for adults with relapsed or refractory marginal zone lymphoma (MZL) after at least two prior treatments. Lisocabtagene maraleucel is also known as liso-cel.

MZL is a type of non-Hodgkin lymphoma that accounts for about 7% of all cases. The median age at diagnosis is 67. People often respond well to their first treatment, but many experience relapse over time, meaning the lymphoma comes back and can require new therapies. When this happens multiple times, treatment options become more limited, creating the need for newer approaches like CAR T-cell therapy. 

Liso-cel is a type of CAR T-cell therapy. It is made from a person’s own immune cells. It has already been approved for several other types of lymphoma, and researchers have been working to understand how well it works for MZL. The FDA approved this therapy because clinical trial results showed strong and long-lasting responses for many people with MZL who had already tried multiple other treatments. 

“The FDA approval of liso-cel in relapsed or refractory marginal zone lymphoma is a significant advancement in redefining the treatment landscape and providing patients with an option that has demonstrated high rates of responses with an established safety profile.”  -M. Lia Palomba, MD

How does liso-cel treat MZL?

Liso-cel works by reengineering a person’s T cells so they can better recognize and target CD19, a protein found on the surface of MZL cells. The T cells are collected, modified in a lab, and then returned to the patient through a one-time infusion. 

Learn More About How CAR-T Works for Lymphoma

The study that led to liso-cel’s approval for MZL

The approval was based on the TRANSCEND FL study, which included a group of adults with relapsed or refractory MZL who had already received at least two treatments or relapsed after a stem cell transplant. 

Of the 66 MZL patients who received liso-cel:

• 95.5% experienced a reduction in cancer cells
• 62.1% experienced complete remission
• At 24 months since responding to treatment, 90.1% of patients continued to remain in remission

What are the common side effects of liso-cel? 

The most common side effects of liso-cel for people with MZL were: 

• Low blood counts
• Neurologic symptoms such as headache, tremor, dizziness, or confusion
• Cytokine release syndrome
• Diarrhea
• Fatigue

Learn How Lymphoma CAR-T Side Effects Are Managed

Next steps for people living with MZL

If you or a loved one has MZL, ask your healthcare team about how your current treatment is working for you and if liso-cel or ongoing studies may be right for you. 

Questions to ask your care team about liso-cel

Consider asking your care team the following questions about liso-cel: 

• Is CAR T-cell therapy a good fit for my health and treatment history?
• What should I expect before, during, and after the infusion?
• What side effects should I watch for at home?
• How will my care team monitor my response after treatment?

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Sources: 

• Bristol Myers Squibb’s Breyanzi Approved by the U.S. FDA as the First and Only CAR T Cell Therapy for Adults with Relapsed or Refractory Marginal Zone Lymphoma (MZL)
• FDA Approves Lisocabtagene Maraleucel for Relapsed or Refractory Marginal Zone Lymphoma
• BREYANZI Prescribing Information