FDA Approves Breyanzi for Marginal Zone Lymphoma Treatment

On December 4, 2025, the U.S. Food and Drug Administration (FDA) approved Breyanzi (Lisocabtagene maraleucel) as the first Chimeric Antigen Receptor (CAR) T-cell therapy for adults with marginal zone lymphoma (MZL) who have failed treatment or relapsed after two or more prior lines of therapy. This approval marks a significant advancement in precision medicine, utilizing genetically engineered T-cells from patients to target and eliminate cancer cells. Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer at the FDA, emphasized that this approval enhances treatment options for patients with rare cancers.

FDA - Food and Drug AdministrationThe Globe and Mail (Toronto)

The efficacy of Breyanzi was evaluated in an open-label, multicenter, single-arm trial involving 77 patients with relapsed or refractory MZL. Of these, 66 patients received the specified single infusion of Breyanzi, resulting in a response rate of 95.5%, with 62.1% achieving complete response as confirmed by imaging scans. The responses were durable, with a median follow-up of 21.6 months. Common adverse reactions included cytokine release syndrome (CRS), diarrhea, fatigue, musculoskeletal pain, and headache.

FDA - Food and Drug AdministrationThe Globe and Mail (Toronto)

Marginal zone lymphoma is a rare, slow-growing cancer that accounts for approximately 7% of all B-cell non-Hodgkin lymphoma cases, with around 7,460 new cases diagnosed annually in the U.S. Patients with MZL who do not respond to initial treatments often face decreased survival rates. The FDA's approval of Breyanzi reflects its commitment to advancing cell therapies for patients with limited treatment options.

FDA - Food and Drug AdministrationThe Globe and Mail (Toronto)

Bristol Myers Squibb (BMY) has positioned Breyanzi as a key component of its oncology portfolio, now approved for five different cancer types, including large B-cell lymphoma and chronic lymphocytic leukemia. The recent approval is expected to bolster Breyanzi's sales, which surged 100% to $966 million in the first nine months of 2025. This growth is attributed to strong demand in existing markets and the expansion into new indications. However, Breyanzi faces competition from Gilead Sciences’ Yescarta and Novartis’ Kymriah, both of which are also CAR T-cell therapies targeting similar patient populations.

The Globe and Mail (Toronto)

The FDA's decision to grant Breyanzi Priority Review and Orphan Drug designation underscores its potential impact on treating MZL. Vijay Kumar, M.D., Acting Director of the Office of Therapeutic Products at the FDA, noted that the approval is part of the agency's ongoing efforts to enhance treatment options for patients with rare cancers.

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Despite the promising results, some experts express caution regarding the long-term efficacy and safety of CAR T-cell therapies like Breyanzi. Concerns about adverse reactions and the high cost of treatment may limit accessibility for some patients.

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“Today’s approval represents a major advancement in precision medicine, essentially turning the patient’s immune system into a more effective tool to treat MZL,” — Vinay Prasad, M.D., M.P.H., Chief Medical and Scientific Officer, FDA.

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“Today’s approval reflects the FDA’s continuing commitment to advance cell therapies to meet the needs of patients with rare cancers,” — Vijay Kumar, M.D., Acting Director, Office of Therapeutic Products, FDA.

FDA - Food and Drug Administration

As Breyanzi becomes available for MZL treatment, ongoing monitoring of its long-term effects and patient outcomes will be essential. The FDA's approval may also prompt further research into CAR T-cell therapies for other rare cancers.

FDA - Food and Drug Administration