Breyanzi (lisocabtagene maraleucel)
An approved treatment for Mantle Cell Lymphoma.
Drug facts
The same compound appears under different names depending on the context. Here is how to identify Lisocabtagene maraleucel wherever you encounter it, plus the key facts at a glance.
- Generic name
- Lisocabtagene maraleucel
- Brand name
- Breyanzi
- Development code
- JCAR017
- Drug class
- CAR T-cell therapy
- Manufacturer
- Bristol Myers Squibb (Juno Therapeutics)
- How it's taken
- One-time infusion into a vein
A one-time CAR T-cell infusion made from the patient's own T cells. For mantle cell lymphoma it is approved for adults whose disease came back or stopped responding after at least 2 lines of treatment, including a BTK inhibitor; in that trial 85% responded and 68% had a complete response. It is also approved for large B-cell, follicular and marginal zone lymphoma and CLL or SLL.
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Where Lisocabtagene maraleucel fits
One of 2 CAR T-cell therapies approved for relapsed or refractory mantle cell lymphoma; Tecartus is the other. Breyanzi's mantle cell lymphoma approval requires earlier treatment with a BTK inhibitor. They have not been compared in a trial.
How Lisocabtagene maraleucel works
T cells are collected from the patient's blood, engineered to carry a chimeric antigen receptor (CAR) that recognizes CD19 on B-cell lymphoma cells, and infused back once. The CAR T cells find and kill CD19-positive lymphoma cells[1]. Before the infusion, patients get 3 days of fludarabine and cyclophosphamide chemotherapy.
Side effects and safety
- Cytokine release syndrome. In 56% of 769 trial patients with non-Hodgkin lymphoma, grade 3 or worse in 3.4%, starting a median of 5 days after infusion.
- Neurologic toxicities. In 32%, grade 3 or worse in 10%, starting a median of 8 days after infusion.
- Prolonged low blood counts. Low counts can last weeks after infusion.
- HLH-like syndrome (IEC-HS). A severe immune overreaction in 7 of 769 patients (0.9%), starting 7 to 32 days after infusion, including fatal cases.
- Allergic reactions. Serious allergic reactions, including anaphylaxis, may occur with the infusion and may be due to the DMSO preservative.
- Secondary cancers. T-cell malignancies have occurred after CD19- and BCMA-directed CAR T-cell therapies, including Breyanzi.
- Daily checks for at least 7 days after infusion
- Stay near a healthcare facility for at least 2 weeks
- No driving for at least 2 weeks
- Blood counts and antibody levels
Breyanzi carries a boxed warning for cytokine release syndrome (CRS), neurologic toxicities and secondary blood cancers, including T-cell malignancies reported after CD19- and BCMA-directed CAR T-cell therapies[1]. Across 769 people with non-Hodgkin lymphoma in its trials, CRS occurred in 56% (grade 3 or worse in 3.4%), starting a median of 5 days after infusion, and neurologic toxicities such as confusion, tremor and trouble speaking occurred in 32% (grade 3 or worse in 10%)[1].
Other warnings include serious infections, low blood counts lasting weeks and low antibody levels[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Lisocabtagene maraleucel
Breyanzi is given once, as an infusion into a vein, 2 to 7 days after 3 days of fludarabine and cyclophosphamide. For mantle cell lymphoma the dose is 90 to 110 million CAR-positive viable T cells. The care team keeps 2 doses of tocilizumab on hand, checks the patient daily for at least 7 days, and the label advises staying near a healthcare facility and not driving for at least 2 weeks afterward[1]. In the mantle cell lymphoma trial, the time from cell collection to infusion was a median of 36 days.
Availability and cost
Only available as the brand-name product.
Help paying for Breyanzi
With private insurance, the drugmaker's copay card can lower what you pay for Breyanzi. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE, but charity funds often can. Of the 3 charity funds for Mantle Cell Lymphoma, 3 were open on October 26, 2026. Pick your insurance below to see which offers fit you.
- Copay help
The Copay Assistance Program covers out-of-pocket costs for the Bristol Myers Squibb CAR T-cell product only, for people with commercial insurance. People with Medicare, Medicaid, TRICARE, VA or other government coverage are not eligible.
For: private insurance · source - Travel help
Transportation, lodging and meal help for eligible patients and a caregiver.
The official page does not say who qualifies. Ask the program. · source - Insurance and case manager help
A patient support navigator is available 24 hours a day at 1-888-805-4555.
The official page does not say who qualifies. Ask the program. · source
Good to know: The Cell Therapy 360 home page describes support for Bristol Myers Squibb CAR T-cell therapies without naming Breyanzi; the Breyanzi label lists the same phone number. Checked on November 2, 2026.
Charity funds for Mantle Cell Lymphoma
- From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)Clinical Trials Co-Pay Fund (all blood cancers) fundOpen
Pays for: Insurance premiums and treatment-related copays, deductibles and coinsurance, up to $3,500 per year. Requires health insurance (any kind).
- From a charity · Blood Cancer United (formerly The Leukemia & Lymphoma Society)Patient Aid Program fundOpen
Pays for: One-time $100 stipend for non-medical expenses (transportation, food, housing, utilities); no income or insurance requirement, up to $100 per year.
The foundation says: “CURRENT FUND STATUS: Open. Fund is currently Open.” - From a charity · HealthWell FoundationMantle Cell Lymphoma fundOpen
Pays for: Prescription copays; Medicare Part B premiums, up to $8,500 per year. Requires health insurance (any kind).
Clinical trial results
The mantle cell lymphoma cohort of its Study 3 (NCT02631044) treated adults with relapsed or refractory mantle cell lymphoma who had already had at least 2 lines of treatment, including a BTK inhibitor, an alkylating agent and an anti-CD20 drug, a median of 3. Among 68 evaluable patients, 85% responded and 68% had a complete response, with a median of 1 month to first response; among all 89 people whose cells were collected, 73% responded[1]. The median age was 69, and 29% had blastoid lymphoma.
Development history
Breyanzi, from Juno Therapeutics, a Bristol Myers Squibb company, was first approved in 2021 for large B-cell lymphoma[1]. Later approvals added CLL and SLL, follicular lymphoma, mantle cell lymphoma after a BTK inhibitor and marginal zone lymphoma. The label asks patients to stay near a healthcare facility for at least 2 weeks after infusion[1].
Explore Mantle Cell Lymphoma trials
Other Mantle Cell Lymphoma treatments
Common questions about Lisocabtagene maraleucel
▸What is Lisocabtagene maraleucel (Breyanzi)?
A one-time CAR T-cell infusion made from the patient's own T cells. For mantle cell lymphoma it is approved for adults whose disease came back or stopped responding after at least 2 lines of treatment, including a BTK inhibitor; in that trial 85% responded and 68% had a complete response. It is also approved for large B-cell, follicular and marginal zone lymphoma and CLL or SLL.
▸How does Lisocabtagene maraleucel work?
T cells are collected from the patient's blood, engineered to carry a chimeric antigen receptor (CAR) that recognizes CD19 on B-cell lymphoma cells, and infused back once. The CAR T cells find and kill CD19-positive lymphoma cells[1]. Before the infusion, patients get 3 days of fludarabine and cyclophosphamide chemotherapy.
▸What are the side effects of Lisocabtagene maraleucel?
Breyanzi carries a boxed warning for cytokine release syndrome (CRS), neurologic toxicities and secondary blood cancers, including T-cell malignancies reported after CD19- and BCMA-directed CAR T-cell therapies[1]. Across 769 people with non-Hodgkin lymphoma in its trials, CRS occurred in 56% (grade 3 or worse in 3.4%), starting a median of 5 days after infusion, and neurologic toxicities such as confusion, tremor and trouble speaking occurred in 32% (grade 3 or worse in 10%)[1]. Other warnings include serious infections, low blood counts lasting weeks and low antibody levels[1].
▸How is Lisocabtagene maraleucel taken?
Breyanzi is given once, as an infusion into a vein, 2 to 7 days after 3 days of fludarabine and cyclophosphamide. For mantle cell lymphoma the dose is 90 to 110 million CAR-positive viable T cells. The care team keeps 2 doses of tocilizumab on hand, checks the patient daily for at least 7 days, and the label advises staying near a healthcare facility and not driving for at least 2 weeks afterward[1]. In the mantle cell lymphoma trial, the time from cell collection to infusion was a median of 36 days.
▸Is Lisocabtagene maraleucel FDA approved?
Yes, Lisocabtagene maraleucel (Breyanzi) is FDA approved (2021) for the treatment of Mantle Cell Lymphoma.
▸How well did Breyanzi work in mantle cell lymphoma?
In its trial of adults whose mantle cell lymphoma came back after at least 2 treatments, including a BTK inhibitor, 85% of the 68 evaluable patients responded and 68% had a complete response[1].
All patients whose cells were collected: 73% of 89 responded.
Speed: the median time to first response was 1 month.
Who was in it: the median age was 69, and 29% had the blastoid form.
Source: Breyanzi prescribing information, March 2026.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Juno Therapeutics via DailyMed · 2026-03-05. Breyanzi (lisocabtagene maraleucel) prescribing information. https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=594bb413-af3b-4b97-afb3-bfe2b174f2ed
- Bristol Myers Squibb. Cell Therapy 360 patient support. https://www.celltherapy360.com/