The FDA has expanded the approval of the CAR T‑cell therapy lisocabtagene maraleucel (liso‑cel; Breyanzi) to include adults with marginal zone lymphoma (MZL) whose disease has come back (relapsed) or has not responded (refractory) after at least two previous courses of systemic drug treatment. This offers a new option for people whose lymphoma is no longer controlled with standard therapies.
How Effective Is Liso-cel?
In the TRANSCEND FL clinical trial, which included a group of patients with relapsed or refractory MZL, about 84% of patients had their lymphoma shrink after receiving liso‑cel (overall response rate). More than half of patients had no signs of active disease on scans, called a complete response, and many of these responses were still ongoing when the data were analyzed, suggesting that benefit can be long‑lasting for some people.
Who Can Receive This Treatment?
Liso‑cel is intended for adults whose MZL has either returned or not responded after at least two prior systemic treatments, typically including antibody‑based and chemotherapy‑type medicines. Because CAR T‑cell therapy is complex and can cause serious side effects, it is usually offered in specialized centers with experience delivering cellular therapies and managing potential complications.
Liso-cel is also approved for certain large B‑cell lymphomas (including diffuse large B‑cell lymphoma and related subtypes), follicular lymphoma, mantle cell lymphoma, and in some settings for chronic lymphocytic leukemia or small lymphocytic lymphoma after multiple prior treatments. Breyanzi is typically offered after other drug regimens have failed, as a one‑time personalized cell therapy given at specialized centers with close monitoring for side effects.
How Is Liso-cel Given?
Liso‑cel is a personalized treatment made from a patient’s own immune cells (T cells). First, blood is collected in a process called leukapheresis to obtain T cells, which are then modified in a laboratory so they can better recognize and attack lymphoma cells and are later infused back into the patient. Before the infusion, patients receive a short course of chemotherapy to “make space” for the CAR T cells, and then get a single infusion of liso‑cel, followed by close monitoring for side effects.
Possible Side Effects and Monitoring
CAR T‑cell therapies can cause significant side effects, so careful observation is essential, especially in the first few weeks after treatment. Common concerns include cytokine release syndrome (often presenting with fever, low blood pressure, and breathing problems), low blood counts that raise the risk of infection or bleeding, and neurologic symptoms such as confusion, headache, or difficulty speaking, which is why patients are often asked to stay near the treatment center for a period of time after infusion.
References
FDA approves lisocabtagene maraleucel for relapsed or refractory marginal zone lymphoma. FDA. 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
FDA grants accelerated approval to lisocabtagene maraleucel for follicular lymphoma. FDA. May 15, 2024. Accessed December 4, 2025. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-grants-accelerated-approval-lisocabtagene-maraleucel-follicular-lymphoma
