FDA Accepts Breyanzi sBLA for Relapsed Marginal Zone Lymphoma

The FDA has accepted a supplemental application for Breyanzi to treat adults with previously treated relapsed or refractory marginal zone lymphoma.

The U.S. Food and Drug Administration (FDA) has accepted the supplemental biologics license application (sBLA) for Breyanzi (lisocabtagene maraleucel; liso-cel) as a potential treatment for adult patients with relapsed or refractory marginal zone lymphoma who have received at least two prior lines of systemic therapy, according to a news release from Bristol Myers Squibb.

In addition, the FDA granted the application priority review and assigned a prescription drug user fee act (PDUFA) goal date of Dec. 5, 2025.

Results from the primary analysis of the marginal zone lymphoma cohort in TRANSCEND FL, a phase 2 open-label, single-arm, multicenter study, supported the application. These data were presented during an oral session at the 2025 International Conference on Malignant Lymphoma (ICML) in June.

A sBLA is submitted when a company seeks approval for changes to an already approved biologic, such as a new indication, formulation or manufacturing process, and may also be eligible for priority review if it meets certain criteria.

Priority review, established under PDUFA, is a process by which the FDA expedites its review of drugs or biologics that may offer significant improvements in safety or effectiveness over existing treatments. Under PDUFA, drug sponsors pay fees to help fund the FDA’s timely review of applications, allowing the agency to meet specific performance goals.

“While initial therapy for marginal zone lymphoma can be effective, multiple relapses over the course of several years are common, leaving patients in need of a new treatment option that can provide high, lasting response rates,” Rosanna Ricafort, vice president, Senior Global Program Lead for Hematology and Cell Therapy, Bristol Myers Squibb, said in the news release. “This FDA acceptance brings us one step closer to potentially standardizing CAR-T cell therapy as a treatment option for marginal zone lymphoma, while building on our commitment to bring this personalized therapy to as many eligible patients as possible.”

The study is evaluating Breyanzi in people with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular and marginal zone types. It is measuring overall response as the primary outcome, with complete response, duration of response and progression-free survival as secondary endpoints.

What is Breyanzi and Marginal Zone Lymphoma?

Breyanzi is a CAR-T cell therapy that targets a protein called CD19 found on certain cancer cells. It includes a 4-1BB costimulatory domain, which helps the engineered T-cells grow and survive longer in the body, improving their ability to fight cancer.

The treatment starts by collecting a patient’s own T-cells from their blood. These cells are then genetically modified to become CAR-T cells that recognize and attack cancer. After this, patients may receive bridging therapy to control their disease while the CAR-T cells are being made. Before infusion, patients undergo lymphodepletion, a chemotherapy step that prepares the body to accept the new cells. Finally, the CAR-T cells are infused back into the patient as a one-time treatment, followed by close monitoring for side effects.

Marginal zone lymphoma is the third most frequent lymphoma type, making up about 7% of non-Hodgkin lymphoma cases. It typically affects patients around 67 years old at diagnosis. This cancer arises when white blood cells gather into lumps within lymph nodes or organs. While initial treatment usually results in remission, relapses are common and can happen multiple times over several years. In some cases, marginal zone lymphoma can change into diffuse large B-cell lymphoma, a more aggressive form.

Reference

1. “Bristol Myers Squibb’s Application for Breyanzi (lisocabtagene maraleucel) Accepted for Priority Review by U.S. Food and Drug Administration (FDA) in Fifth Cancer Type for Relapsed or Refractory Marginal Zone Lymphoma (MZL),” Bristol Myers Squibb. News Release. Aug. 4, 2025.

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