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In the MZL cohort of TRANSCEND FL, Breyanzi delivered deep and durable responses in 95.5% of patients while demonstrating a consistent safety profile
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Breyanzi is now the only CAR T cell therapy approved by the FDA for five cancer types, the most of any CD19-directed CAR T cell therapy
December 04, 2025--PRINCETON, N.J.--(BUSINESS WIRE)-- Bristol Myers Squibb (NYSE: BMY) today announced that the U.S. Food and Drug Administration (FDA) has granted approval of Breyanzi® (lisocabtagene maraleucel; liso-cel), a CD19-directed chimeric antigen receptor (CAR) T cell therapy, for the treatment of adult patients with relapsed or refractory (R/R) marginal zone lymphoma (MZL) who have received at least two prior lines of systemic therapy. Breyanzi is administered as a one-time infusion*. Please see the Important Safety Information section below, including Boxed WARNINGS for Breyanzi regarding Cytokine Release Syndrome (CRS), Neurologic Toxicities, and Secondary Hematological Malignancies.
“The FDA approval of Breyanzi for relapsed or refractory marginal zone lymphoma further solidifies it as the leading CD19-directed CAR T cell therapy covering the broadest range of B-cell malignancies. This approval in a fifth cancer type reflects our bold vision to bring the transformational potential of cell therapy to more patients," said Lynelle B. Hoch, president, Cell Therapy Organization, Bristol Myers Squibb. “Breyanzi is the first and only CAR T cell therapy approved for this patient population, demonstrating Bristol Myers Squibb’s deep commitment to expanding access and reaching as many patients as possible with this innovative, practice-changing treatment.”
This approval of Breyanzi is based on results from the MZL cohort in TRANSCEND FL, an open-label, multicenter, multi-cohort, single-arm study. Based on the U.S. Prescribing Information (USPI), in patients treated with Breyanzi in the third-line plus setting and included in the primary efficacy analysis set (n=66), the overall response rate (ORR) was 95.5% (95% CI: 87.3-99.1). ORR was defined as the percentage of patients achieving a partial or complete response per the Lugano criteria assessed by an Independent Review Committee (IRC) per CT. The complete response (CR) rate was 62.1% (95% CI: 49.3-73.8). The median duration of response (mDOR) was not reached (95% CI: 25.59-NR), with 90.1% of responders remaining in response at 24 months.
“Patients living with marginal zone lymphoma, a subtype of indolent non-Hodgkin lymphoma, generally see success with initial therapy, but a subset of patients ultimately experience multiple relapses over the course of many years, creating a pressing need for new treatment options with durable outcomes,” said M. Lia Palomba, M.D., TRANSCEND FL study investigator and lymphoma and cell therapy specialist, Memorial Sloan Kettering Cancer Center. “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.”
The safety profile of Breyanzi in R/R MZL was consistent with prior reports from trials in other indications. In the MZL cohort of the TRANSCEND FL study, any grade cytokine release syndrome (CRS) occurred in 76% of patients, including Grade ≥3 CRS in 4.5% of patients. Any grade nervous system disorders included: headache (21%), tremor (21%), encephalopathy (21%), dizziness (16%), and aphasia (10%), including Grade ≥3 headache (1.5%) and Grade ≥3 encephalopathy (1.5%). Patients in the MZL cohort of the TRANSCEND FL study were treated in the inpatient and outpatient setting since the safety profile of Breyanzi allows for the option of outpatient treatment and adverse event management for appropriate patients.
Breyanzi is broadly covered by commercial and government insurance programs in the U.S. Bristol Myers Squibb offers various programs and resources to address the needs of patients and care partners that support their CAR T cell therapy treatment journey. Bristol Myers Squibb also supports the patient and physician treatment experience by providing Cell Therapy 360, a digital service platform, which optimizes access to relevant information, manufacturing updates, and patient and care partner support.
*The treatment process includes blood collection, CAR T cell creation, potential bridging therapy, lymphodepletion, administration, and side-effect monitoring.
About TRANSCEND FL
TRANSCEND FL (NCT04245839) is an open-label, global, multicenter, Phase 2, single-arm study to determine the efficacy and safety of Breyanzi in patients with relapsed or refractory indolent B-cell non-Hodgkin lymphoma, including follicular lymphoma and marginal zone lymphoma. The primary outcome measure is overall response rate. Secondary outcome measures include complete response rate, duration of response, and progression-free survival.
About MZL
Marginal zone lymphoma (MZL) is a subtype of non-Hodgkin lymphoma (NHL), accounting for about 7% of all NHL cases. Most patients with MZL are diagnosed at a median age of 67 years. MZL develops when white blood cells cluster together to form lumps in a person’s lymph nodes or organs. Initial therapy often leads to remission, but relapse is common, sometimes occurring several times over many years. A small portion of MZL cases transform into diffuse large B-cell lymphoma, a more aggressive lymphoma.
About Breyanzi
Breyanzi is a CD19-directed CAR T cell therapy with a 4-1BB costimulatory domain, which enhances the expansion and persistence of the CAR T cells. Breyanzi is made from a patient’s own T cells, which are collected and genetically reengineered to become CAR T cells that are then delivered via infusion as a one-time treatment. The treatment process includes blood collection, CAR T cell creation, potential bridging therapy, lymphodepletion, administration, and side-effect monitoring.
Breyanzi is approved in the U.S. for the treatment of relapsed or refractory large B-cell lymphoma (LBCL) after at least one prior line of therapy, has received accelerated approval for the treatment of relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) after at least two prior lines of therapy, relapsed or refractory follicular lymphoma (FL) after two or more prior lines of systemic therapy, and is approved for the treatment of relapsed or refractory mantle cell lymphoma (MCL) after at least two prior lines of systemic therapy. Breyanzi is also approved in Japan, the European Union (EU), Switzerland, Israel, the United Kingdom (UK), and Canada for the treatment of relapsed or refractory LBCL after at least one prior line of therapy; in Japan for the treatment of patients with relapsed or refractory high-risk FL after one prior line of systemic therapy, and in patients with relapsed or refractory FL after two or more lines of systemic therapy; in the EU, Switzerland, Israel, and the UK for the treatment of relapsed or refractory FL after two or more lines of systemic therapy; and in the EU and Israel for the treatment of relapsed or refractory MCL after at least two lines of systemic therapy including a Bruton’s tyrosine kinase (BTK) inhibitor.
About Bristol Myers Squibb
Bristol Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases.