Lisocabtagene maraleucel

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Lisocabtagene maraleucel (Breyanzi) is a CAR-T cell therapy used to treat certain B-cell lymphomas. It uses a patient’s own T cells, which are engineered to target CD19 on B cells and then given back to the patient as a single intravenous infusion after a short course of chemotherapy.

What it treats
- Approved in the United States for adults with relapsed or refractory large B-cell lymphomas, including diffuse large B-cell lymphoma (DLBCL) and other related B-cell cancers.
- Also approved for follicular lymphoma grade 3B and certain other B-cell conditions.
- In the European Union, approved for adults with DLBCL, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B that relapsed within 12 months or is refractory to first-line therapy.
- Expanded indications: In May 2024, the FDA added treatment for:
- Adults with relapsed or refractory follicular lymphoma after two or more prior therapies
- Adults with relapsed or refractory mantle cell lymphoma after at least two prior therapies (including a BTK inhibitor)
- In December 2025, the FDA added relapsed or refractory marginal zone lymphoma after two prior therapies.
- Not approved for primary central nervous system lymphoma.

How it works and how it’s given
- It is a CAR-T cell therapy: a patient’s T cells are collected, genetically modified to attack CD19, and then infused back into the patient.
- Administered as a single infusion after lymphodepleting chemotherapy (usually with drugs like fludarabine and cyclophosphamide).

Efficacy
- In a key trial for refractory/relapsed large B-cell lymphoma, about half of patients achieved complete remission after treatment.
- Efficacy has been studied in other trials for follicular lymphoma and related conditions.

Safety and warnings
- The most important safety concerns are cytokine release syndrome (CRS) and neurologic toxicities, which can be serious.
- Other common side effects include low blood cell counts (neutropenia, anemia, low platelets), infections, fatigue, fever, headache, and musculoskeletal pain.
- The FDA requires boxed warnings for CRS and T-cell–related malignancies, reflecting these risks and the need for monitoring in specialized centers. An expanded boxed warning also covers T-cell malignancies.
- Because of potential serious adverse effects, patients are treated in settings equipped to monitor and manage complications.

Key points
- Lisocabtagene maraleucel is a one-time CAR-T therapy for select relapsed or refractory B-cell lymphomas.
- It has grown in approved uses over time, with expanding indications in the US and EU.
- While effective for many patients, it carries risks that require careful medical supervision and specialized care.