Lisocabtagene Maraleucel

BREYANZI is a CD19-directed genetically modified autologous cell immunotherapy administered as a defined composition to reduce variability in CD8-positive and CD4-positive T cell dose. The CAR is comprised of an FMC63 monoclonal antibody-derived single chain variable fragment (scFv), IgG4 hinge region, CD28 transmembrane domain, 4-1BB (CD137) costimulatory domain, and CD3 zeta activation domain.

• BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy 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. ( 1.1 ) Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.ICD-10: C85.90

• None. None.contraindicated

For autologous use only. For intravenous use only. • Do NOT use a leukodepleting filter. ( 2.2 ) • Administer a lymphodepleting regimen of fludarabine and cyclophosphamide before infusion of BREYANZI. ( 2.2 ) • Verify the patient’s identity prior to infusion. ( 2.2 ) • Premedicate with acetaminophen and an H 1 antihistamine. ( 2.2 ) • Confirm availability of tocilizumab prior to infusion. ( 2.2 , 5.1 ) • Dosing of BREYANZI is based on the number of chimeric antigen receptor (CAR)-positive viable T cells. ( 2.1 ) For LBCL : • after one line of therapy, the dose is 90 to 110 × 10 6 CAR-positive viable T cells. ( 2.1 ) • after two or more lines of therapy, the dose is 50 to 110 × 10 6 CAR-positive viable T cells. ( 2.1 ) For CLL/SLL, FL, MCL and MZL : • the dose is 90 to 110 × 10 6 CAR-positive viable T cells. ( 2.1 ) 2.1 Dose For autologous use only. For intravenous use only. See the respective Certificate of Release for Infusion (RFI Certificate) for each component, for the actual cell counts and volumes to be infused [see Dosage and Administration ( 2.2 ) and Dosage Forms and Strengths ( 3 )]. A single dose of BREYANZI contains CAR-positive viable T cells (consisting of 1:1 CAR-positive viable T cells of the CD8 and CD4 components), with each component supplied separately in one to four single-dose vials. See Table 1 for dose range per indication. Table 1: Dose Range Abbreviations: LBCL = large B-cell lymphoma; CLL = chronic lymphocytic leukemia; SLL = small lymphocytic lymphoma; FL = follicular lymphoma; MCL = mantle cell lymphoma; MZL = marginal zone lymphoma.

• Hypersensitivity Reactions: Monitor for hypersensitivity reactions during infusion. ( 5.3 ) • Serious Infections: Monitor patients for signs and symptoms of infection; treat appropriately. ( 5.4 ) • Prolonged Cytopenias: Patients may exhibit Grade 3 or higher cytopenias for several weeks following BREYANZI infusion. Monitor complete blood counts. ( 5.5 ) • Hypogammaglobulinemia: Monitor and consider immunoglobulin replacement therapy. ( 5.6 ) • 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. ( 5.7 ) 5.1 Cytokine Release Syndrome Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which included a total of 769 patients with non-Hodgkin lymphoma (NHL) exposed to BREYANZI, CRS occurred in 56% of patients, including ≥ Grade 3 CRS (Lee grading system 1 ) in 3.4% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 99% of patients with a median duration of 5 days (range: 1 to 37 days). One patient had fatal CRS and 5 patients had ongoing CRS at the time of death. The most common manifestations of CRS (≥ 10%) included fever, hypotension, chills, tachycardia, hypoxia, and headache.

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. ( 6.1 ) • 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. ( 6.1 ) • FL are CRS. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decreased, neutrophil count decreased, and white blood cell decreased. ( 6.1 ) • 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. ( 6.1 ) • MZL are CRS. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decreased, neutrophil count decreased, and white blood cell decreased. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.

8.1 Pregnancy Risk Summary There are no available data with BREYANZI use in pregnant women. No animal reproductive and developmental toxicity studies have been conducted with BREYANZI to assess whether it can cause fetal harm when administered to a pregnant woman. It is not known if BREYANZI has the potential to be transferred to the fetus. Based on the mechanism of action, if the transduced cells cross the placenta, they may cause fetal toxicity, including B-cell lymphocytopenia and hypogammaglobulinemia. Therefore, BREYANZI is not recommended for women who are pregnant, and pregnancy after BREYANZI infusion should be discussed with the treating physician. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. 8.2 Lactation Risk Summary There is no information regarding the presence of BREYANZI in human milk, the effect on the breastfed infant, and the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for BREYANZI and any potential adverse effects on the breastfed infant from BREYANZI or from the underlying maternal condition.

Metabolism

Following infusion, BREYANZI exhibited an initial expansion followed by a bi-exponential decline. Relapsed or Refractory LBCL The median time of maximal expansion in peripheral blood occurred 10-12 days after infusion.

1. 1Cytokine Release Syndrome34243%
2. 2Immune Effector Cell-associated Neurotoxicity Syndrome14718%
3. 3Neurotoxicity10213%
4. 4Pyrexia496.1%
5. 5Fatigue394.9%
6. 6Hypotension384.8%
7. 7Confusional State293.6%
8. 8Death273.4%
9. 9Disease Progression253.1%
10. 10Febrile Neutropenia253.1%
11. 11Lymphocyte Adoptive Therapy253.1%
12. 12Platelet Count Decreased253.1%
13. 13Aphasia232.9%
14. 14Malignant Neoplasm Progression232.9%
15. 15Tremor222.8%

The 10 most recently updated of 30 ClinicalTrials.gov registrations naming Lisocabtagene Maraleucel as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study of the Efficacy and Safety of Lisocabtagene Maraleucel (Liso-cel) as First-Line Therapy in Adults With Transplant-Ineligible Primary Central Nervous System Lymphoma
  Recruiting · Phase 2 · Interventional · 65 enrolled · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
  NCT07015242updated 2026-06-10
• Lisocabtagene Maraleucel, Nivolumab and Ibrutinib for the Treatment of Richter's Transformation
  Active not recruiting · Phase 2 · Interventional · 9 enrolled · City of Hope Medical Center
  NCT05672173updated 2026-06-09
• A Study to Investigate Ronde-cel Versus Investigator's Choice CD19 CAR T-Cell Therapy
  Recruiting · Phase 3 · Interventional · 400 enrolled · Lyell Immunopharma, Inc.
  NCT07188558updated 2026-06-08
• Nemtabrutinib and Lisocabtagene Maraleucel for the Treatment of Relapsed/Refractory Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
  Recruiting · Phase 2 · Interventional · 20 enrolled · Fred Hutchinson Cancer Center
  NCT07194980updated 2026-06-05
• Phase 2 Trial of Lisocabtagene Maraleucel for Minimal Residual Disease in Patients With Large B-cell Lymphoma
  Active not recruiting · Phase 2 · Interventional · 50 enrolled · M.D. Anderson Cancer Center
  NCT07316010updated 2026-05-26
• NT-I7 (Efineptakin Alfa), a Long-acting Human IL-7, Post-Axicabtagene Ciloleucel or Post-Lisocabtagene Maraleucel in Subjects With Relapsed/Refractory Large B-cell Lymphoma
  Recruiting · Phase 1 · Interventional · 24 enrolled · Washington University School of Medicine
  NCT07052305updated 2026-05-13
• NKTR-255 in Combination With CAR-T Cell Therapy for the Treatment of Relapsed or Refractory Large B-cell Lymphoma
  Active not recruiting · Phase 1 · Interventional · 27 enrolled · Fred Hutchinson Cancer Center
  NCT05359211updated 2026-03-20
• A Study to Evaluate the Efficacy and Safety of Liso-cel Compared to Standard of Care in Adults With Relapsed or Refractory Follicular Lymphoma
  Withdrawn · Phase 3 · Interventional · 0 enrolled · Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
  NCT06313996updated 2026-03-18
• Study Evaluating Safety and Efficacy of JCAR017 in Subjects With Relapsed or Refractory Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)
  Recruiting · Phase 1 · Phase 2 · Interventional · 320 enrolled · Juno Therapeutics, a Subsidiary of Celgene
  NCT03331198updated 2026-03-04
• Zanubrutinib and Lisocabtagene Maraleucel for the Treatment of Richter's Syndrome
  Recruiting · Phase 2 · Interventional · 24 enrolled · Aseel Alsouqi
  NCT05873712updated 2026-03-03

Frequently asked questions

How does Lisocabtagene Maraleucel work?

BREYANZI is a CD19-directed genetically modified autologous cell immunotherapy administered as a defined composition to reduce variability in CD8-positive and CD4-positive T cell dose. The CAR is comprised of an FMC63 monoclonal antibody-derived single chain variable fragment (scFv), IgG4 hinge region, CD28 transmembrane domain, 4-1BB (CD137) costimulatory domain, and CD3 zeta activation domain.

What is Lisocabtagene Maraleucel used for?

According to FDA labeling, Lisocabtagene Maraleucel carries indications including: BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy 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. ( 1.1 ) Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Lisocabtagene Maraleucel?

Lisocabtagene Maraleucel is classified as Antineoplastic cell and gene therapy, CD19-directed Antibody Interactions.

What are the brand names for Lisocabtagene Maraleucel?

Lisocabtagene Maraleucel is marketed under brand names including Breyanzi.

What are the contraindications for Lisocabtagene Maraleucel?

Lisocabtagene Maraleucel labeling lists contraindications including: None. None.. Always consult the full prescribing information and a clinician.