Give patients THE ONE CAR T proven in R/R LBCL for both transplant-eligible and transplant-ineligible patients1

Patient journey1

CAR T-cell treatment journey

Follow-up1

Calendar

After at least 2 weeks of monitoring in close proximity to a healthcare facility, the patient may return to their primary oncologist for long-term monitoring and appointments

Clipboard

Continue to monitor for signs and symptoms of CRS and NT

Car

Patients should avoid driving for at least 2 weeks after their Breyanzi® infusion

Monitor complete blood count for AEs

Continue to monitor complete blood count and watch for signs and symptoms of serious infections, febrile neutropenia, prolonged cytopenias, B-cell aplasia, hypogammaglobulinemia, and secondary malignancies

Monitor for secondary malignancies and contact BMS to report

Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, including T-cell malignancies, contact Bristol Myers Squibb at 1-888-805-4555 for reporting and instructions

Breyanzi registry to monitor for secondary malignancies

Patients may be enrolled in the Breyanzi registry, which will monitor safety for up to 15 years. Patients should also be monitored lifelong for potential secondary malignancies

Treatment center finder

Breyanzi is currently offered at treatment centers across the United States, and more may continue to be added

Breyanzi manufacturing1

Leukapheresis

T cells are collected via leukapheresis at a qualified center.

Manufacturing

Cells are sent to a manufacturing site for purification, engineering, and expansion, delivering a defined ratio of CAR-positive viable T cells (consisting of 1:1 CD8 and CD4 components). Ensure that patients understand the risk (11%) of manufacturing failure. Rates of manufacturing failure in the commercial setting differ from rates in the clinical trial.

Infusion

Breyanzi is delivered as separate vials of CD8-positive and CD4-positive cells. Lymphodepletion chemotherapy (fludarabine 30 mg/m2/day and cyclophosphamide 300 mg/m2/day concurrently for 3 days) should be completed 2 to 7 days before administration of Breyanzi.

A single dose of Breyanzi contains 90 to 110 × 106 CAR-positive viable T cells (consisting of 1:1 CAR-positive viable T cells of the CD8 and CD4 components). The manufacturing target dose is 100 × 106 CAR-positive viable T cells.

Physician is notified of estimated Breyanzi availability date, which is subject to change. Confirm availability before starting lymphodepletion.

Short-term monitoring

Monitor patients daily at a healthcare facility during the first week following infusion for signs and symptoms of CRS and neurologic toxicities.

Instruct patients to remain within proximity of a healthcare facility for at least 2 weeks following infusion.

CAR, chimeric antigen receptor; CRS, cytokine release syndrome; LBCL, large B-cell lymphoma; MOA, mechanism of action; NT, neurologic toxicity; R/R, relapsed or refractory.

Breyanzi is designed for gradual expansion* and persistence1

Smart engineering: Breyanzi is a CD19-directed CAR T-cell therapy

Cell receptor

The 4-1BB co-stimulatory domain signaling enhances the expansion and persistence of Breyanzi1

CD4 and CD8 CAR T cells

Defined and purified† product–defined ratio reduces variability of the CD8 and CD4 component dose1

CAR T-cells infusion bag

Breyanzi is administered as a one-time infusion1‡

Breyanzi was present in the peripheral blood for at least 2 years1

Breyanzi binds to CD19 expressed on the cell surface of tumor and normal B cells, inducing activation of CAR T cells and killing target cells.1

The binding region of the CAR is composed of a CD19-directed, antibody-derived, single-chain variable fragment1

Breyanzi cell receptor
  1. Extracellular receptor-binding region
  2. IgG4 hinge region
  3. CD28 transmembrane domain
  4. The receptor is fused to intracellular signaling domains, including a 4-1BB co-stimulatory domain to enhance the expansion and persistence
  5. CD3 zeta activation domain

*The median time of maximal expansion in peripheral blood occurred 10-12 days after infusion.1

†The purified CD8-positive and CD4-positive T cells are separately activated and transduced with the replication-incompetent lentiviral vector containing the anti-CD19 CAR transgene.1

‡Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring. A single dose of Breyanzi is 90 to 110 x 106 CAR-positive viable T cells for LBCL after 1 line of therapy, and 50 to 110 x 106 for LBCL after 2 or more lines of therapy (consisting of 1:1 CAR-positive viable T cells of the CD8 and CD4 components), with each component supplied separately in 1 to 4 single-dose vials.1

CAR, chimeric antigen receptor; LBCL, large B-cell lymphoma; R/R, relapsed or refractory.

References

  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2025.

Important Safety Information

Indications

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 two or more lines of systemic therapy.

Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.

Important Safety Information

WARNING: CYTOKINE RELEASE SYNDROME, NEUROLOGIC TOXICITIES, AND SECONDARY HEMATOLOGICAL MALIGNANCIES

  • Cytokine Release Syndrome (CRS), including fatal or life-threatening reactions, occurred in patients receiving BREYANZI. Do not administer BREYANZI to patients with active infection or inflammatory disorders. Treat severe or life-threatening CRS with tocilizumab with or without corticosteroids.
  • Neurologic toxicities, including fatal or life-threatening reactions, occurred in patients receiving BREYANZI, including concurrently with CRS, after CRS resolution, or in the absence of CRS. Monitor for neurologic events after treatment with BREYANZI. Provide supportive care and/or corticosteroids as needed.
  • T cell malignancies have occurred following treatment of hematologic malignancies with BCMA- and CD19-directed genetically modified autologous T cell immunotherapies, including BREYANZI.

Cytokine Release Syndrome

Cytokine release syndrome (CRS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. In clinical trials of BREYANZI, which enrolled a total of 702 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 54% of patients, including ≥ Grade 3 CRS in 3.2% of patients. The median time to onset was 5 days (range: 1 to 63 days). CRS resolved in 98% 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%) were fever, hypotension, tachycardia, chills, hypoxia, and headache.

Serious events that may be associated with CRS include cardiac arrhythmias (including atrial fibrillation and ventricular tachycardia), cardiac arrest, cardiac failure, diffuse alveolar damage, renal insufficiency, capillary leak syndrome, hypotension, hypoxia, and hemophagocytic lymphohistiocytosis/macrophage activation syndrome (HLH/MAS).

Ensure that 2 doses of tocilizumab are available prior to infusion of BREYANZI.

Neurologic Toxicities

Neurologic toxicities that were fatal or life-threatening, including immune effector cell-associated neurotoxicity syndrome (ICANS), occurred following treatment with BREYANZI. Serious events including cerebral edema and seizures occurred with BREYANZI. Fatal and serious cases of leukoencephalopathy, some attributable to fludarabine, also occurred.

In clinical trials of BREYANZI, CAR T cell-associated neurologic toxicities occurred in 31% of patients, including ≥ Grade 3 cases in 10% of patients. The median time to onset of neurotoxicity was 8 days (range: 1 to 63 days). Neurologic toxicities resolved in 88% of patients with a median duration of 7 days (range: 1 to 119 days). Of patients developing neurotoxicity, 82% also developed CRS.

The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, headache, dizziness, and delirium.

CRS and Neurologic Toxicities Monitoring

Monitor patients daily for at least 7 days following BREYANZI infusion for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 2 weeks after infusion and treat promptly. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated. Manage neurologic toxicity with supportive care and/or corticosteroid as needed. Advise patients to avoid driving for at least 2 weeks following infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time.

Hypersensitivity Reactions

Allergic reactions may occur with the infusion of BREYANZI. Serious hypersensitivity reactions, including anaphylaxis, may be due to dimethyl sulfoxide (DMSO).

Serious Infections

Severe infections, including life-threatening or fatal infections, have occurred in patients after BREYANZI infusion. In clinical trials of BREYANZI, infections of any grade occurred in 34% of patients, with Grade 3 or higher infections occurring in 12% of all patients. Grade 3 or higher infections with an unspecified pathogen occurred in 7%, bacterial infections in 3.7%, viral infections in 2%, and fungal infections in 0.7% of patients. One patient who received 4 prior lines of therapy developed a fatal case of John Cunningham (JC) virus progressive multifocal leukoencephalopathy 4 months after treatment with BREYANZI. One patient who received 3 prior lines of therapy developed a fatal case of cryptococcal meningoencephalitis 35 days after treatment with BREYANZI.

Febrile neutropenia developed after BREYANZI infusion in 8% of patients. Febrile neutropenia may be concurrent with CRS. In the event of febrile neutropenia, evaluate for infection and manage with broad-spectrum antibiotics, fluids, and other supportive care as medically indicated.

Monitor patients for signs and symptoms of infection before and after BREYANZI administration and treat appropriately. Administer prophylactic antimicrobials according to standard institutional guidelines. Avoid administration of BREYANZI in patients with clinically significant, active systemic infections.

Viral reactivation: Hepatitis B virus (HBV) reactivation, in some cases resulting in fulminant hepatitis, hepatic failure, and death, can occur in patients treated with drugs directed against B cells. In clinical trials of BREYANZI, 35 of 38 patients with a prior history of HBV were treated with concurrent antiviral suppressive therapy. Perform screening for HBV, HCV, and HIV in accordance with clinical guidelines before collection of cells for manufacturing. In patients with prior history of HBV, consider concurrent antiviral suppressive therapy to prevent HBV reactivation per standard guidelines.

Prolonged Cytopenias

Patients may exhibit cytopenias not resolved for several weeks following lymphodepleting chemotherapy and BREYANZI infusion. In clinical trials of BREYANZI, Grade 3 or higher cytopenias persisted at Day 29 following BREYANZI infusion in 35% of patients, and included thrombocytopenia in 25%, neutropenia in 22%, and anemia in 6% of patients. Monitor complete blood counts prior to and after BREYANZI administration.

Hypogammaglobulinemia

B-cell aplasia and hypogammaglobulinemia can occur in patients receiving BREYANZI. In clinical trials of BREYANZI, hypogammaglobulinemia was reported as an adverse reaction in 10% of patients. Hypogammaglobulinemia, either as an adverse reaction or laboratory IgG level below 500 mg/dL after infusion, was reported in 30% of patients. Monitor immunoglobulin levels after treatment with BREYANZI and manage using infection precautions, antibiotic prophylaxis, and immunoglobulin replacement as clinically indicated.

Live vaccines: The safety of immunization with live viral vaccines during or following BREYANZI treatment has not been studied. Vaccination with live virus vaccines is not recommended for at least 6 weeks prior to the start of lymphodepleting chemotherapy, during BREYANZI treatment, and until immune recovery following treatment with BREYANZI.

Secondary Malignancies

Patients treated with BREYANZI may develop 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. Mature T cell malignancies, including CAR-positive tumors, may present as soon as weeks following infusion, and may include fatal outcomes. Monitor lifelong for secondary malignancies. In the event that a secondary malignancy occurs, contact Bristol-Myers Squibb at 1-888-805-4555 for reporting and to obtain instructions on collection of patient samples for testing.

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS)

Immune Effector Cell-Associated Hemophagocytic Lymphohistiocytosis-Like Syndrome (IEC-HS), including fatal or life-threatening reactions, occurred following treatment with BREYANZI. IEC-HS is a life-threatening condition with a high mortality rate if not recognized and treated early. Treatment of IEC-HS should be administered per current practice guidelines.

Adverse Reactions

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

  • LBCL are fever, cytokine release syndrome, 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.

Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

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2009-US-2500226

09/2025