Bristol-Myers Squibb Breyanzi (lisocabtagene maraleucel) Monograph

Published: March 03, 2026

Breyanzi (lisocabtagene maraleucel) is a CD19-directed genetically modified autologous T-cell immunotherapy indicated for the treatment of large B-cell lymphoma (LBCL), chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), follicular lymphoma (FL), mantle cell lymphoma (MCL), and marginal zone lymphoma (MZL) in adults. Breyanzi was first approved in February of 2021, and has since received additional approvals. Read on to learn more about Breyanzi, including its approvals, dosage and administration information, adverse reactions, and more.

Medication Overview:

Brand Name: Breyanzi
Generic Name: lisocabtagene maraleucel
Treatment for: Large B-Cell Lymphoma, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Follicular Lymphoma, Mantle Cell Lymphoma, Marginal Zone Lymphoma
Manufacturer: Bristol-Myers Squibb
Initial FDA Approval: February 2021

Indicated Condition	Indication	Age	Date Approved
Large B-cell Lymphoma (LBCL)	Indicated for the treatment of adult patients with large B-cell lymphoma (LBCL), including diffuse large B-cell lymphoma (DLBCL) not otherwise specified (including DLBCL arising from indolent lymphoma), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, and follicular lymphoma grade 3B, who have: refractory disease to first-line chemoimmunotherapy or relapse within 12 months of first-line chemoimmunotherapy; or refractory disease to first-line chemoimmunotherapy or relapse after first-line chemoimmunotherapy and are not eligible for hematopoietic stem cell transplantation (HSCT) due to comorbidities or age; or relapsed or refractory disease after 2 or more lines of systemic therapy. Limitations of Use: Breyanzi is not indicated for the treatment of patients with primary central nervous system lymphoma.	Adults	February 2021
Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)	Indicated for the treatment of adult patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least 2 prior lines of therapy, including a Bruton tyrosine kinase (BTK) inhibitor and a B-cell lymphoma 2 (BCL-2) inhibitor. This indication is approved under accelerated approval based on response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).	Adults	March 2024
Relapsed or Refractory Follicular Lymphoma (FL)	Indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received 2 or more prior lines of systemic therapy.	Adults	May 2024
Relapsed or Refractory Mantle Cell Lymphoma (MCL)	Indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL) who have received at least 2 prior lines of systemic therapy, including a Bruton tyrosine kinase (BTK) inhibitor.	Adults	May 2024
Relapsed or Refractory Marginal Zone Lymphoma (MZL)	Indicated for the treatment of adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least 2 prior lines of systemic therapy.	Adults	December 2025

Warnings and Precautions:

Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion
Serious Infections: Monitor patients for signs and symptoms of infection; treat appropriately.
Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following Breyanzi infusion. Monitor complete blood counts.
Hypogammaglobulinemia: Monitor and consider immunoglobulin replacement therapy.
Secondary Malignancies: T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including Breyanzi. In the event that a secondary malignancy occurs after treatment with Breyanzi, contact Bristol-Myers Squibb at 1-888-805-4555.

Dosage and Administration:

For autologous use only. For intravenous use only.

Do NOT use a leukodepleting filter.
Administer a lymphodepleting regimen of fludarabine and cyclophosphamide before infusion of Breyanzi.
Verify the patient’s identity prior to infusion.
Premedicate with acetaminophen and an H1 antihistamine.
Confirm availability of tocilizumab prior to infusion.
Dosing of Breyanzi is based on the number of chimeric antigen receptor (CAR)-positive viable T cells.

For LBCL: after one line of therapy, the dose is 90 to 110 × 106 CAR-positive viable T cells; after two or more lines of therapy, the dose is 50 to 110 × 106 CAR-positive viable T cells.

For CLL/SLL, FL, MCL and MZL: the dose is 90 to 110 × 106 CAR-positive viable T cells.

Contraindications:

None.

Drug Interactions:

HIV and the lentivirus used to make Breyanzi have limited, short spans of identical genetic material (RNA). Therefore, some commercial HIV nucleic acid tests may yield false-positive results in patients who have received Breyanzi.

Adverse Reactions:

The most common adverse reactions (incidence ≥30%) in:

LBCL are fever, CRS, fatigue, musculoskeletal pain, and nausea. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, platelet count decrease, and hemoglobin decrease.
CLL/SLL are CRS, encephalopathy, fatigue, musculoskeletal pain, nausea, edema and diarrhea. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, hemoglobin decrease, platelet count decrease, and lymphocyte count decrease.
FL are CRS. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decreased, neutrophil count decreased, and white blood cell decreased.
MCL are CRS, fatigue, musculoskeletal pain, and encephalopathy. The most common Grade 3-4 laboratory abnormalities include neutrophil count decrease, white blood cell decrease, and platelet count decrease.
MZL are CRS. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decreased, neutrophil count decreased, and white blood cell decreased.

Example of Lisocabtagene Maraleucel in a Guideline

Immunotherapy for the Treatment of Lymphoma

Society for Immunotherapy of Cancer, March 2025
“Lisocabtagene maraleucel is recommended for adult patients with relapsed or refractory CLL or SLL who have received at least 2 prior lines of therapy, including a BTK inhibitor and a BCL-2 inhibitor.”

Please note: This article is current as of February 25, 2026. Consult our clinical guidelines library or drug information tool to ensure you always have the most up-to-date information.