Breyanzi®: THE ONE with a safety profile you can count on1

In both clinical trials and the real-world setting, most CRS and NT events occurred and resolved quickly.1,2

Cytokine release syndrome (CRS) rates in the MZL cohort of TRANSCEND FL clinical trial. 56% of patients experienced any grade of CRS and 3.4% of patients experienced grade 3 or higher of CRS. Median time to onset was 5 days and median duration was 5 days

CRS-related clinical trial details (N=769)1,2

  • Prophylactic systemic corticosteroids were not used in Breyanzi trials
  • CRS resolved in 99% of patients with a median duration of 5 (range: 1-37) 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

Cytokine release syndrome warnings and precautions1

  • CRS, including fatal or life-threatening reactions, occurred following treatment with Breyanzi
  • 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
  • Ensure that 2 doses of tocilizumab are available prior to infusion of Breyanzi
  • Monitor patients daily for at least 7 days following Breyanzi infusion for signs and symptoms of CRS. Continue to monitor patients for signs or symptoms of CRS for at least 2 weeks after infusion. At the first sign of CRS, institute treatment with supportive care, tocilizumab, or tocilizumab and corticosteroids as indicated
  • Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time

Breyanzi offers the flexibility of inpatient or outpatient administration for appropriate patients1

MZL Cohort of TRANSCEND FL trial design (N=77): TRANSCEND FL was an open-label, multicenter, single-arm trial in adult patients. The MZL Cohort included patients with R/R MZL who received ≥2 prior lines of systemic therapy. The primary endpoint was ORR. In this trial 77 patients underwent leukapheresis, 67 patients were treated with Breyanzi, and 66 patients were included in the treated efficacy set.1

CRS, cytokine release syndrome; FL, follicular lymphoma; MZL, marginal zone lymphoma; NT, neurologic toxicity; ORR, overall response rate; R/R, relapsed or refractory.

Neurologic toxicity rates in the MZL cohort of TRANSCEND FL clinical trial. 32% of patients experienced any grade of NTs and 10% of patients experienced grade 3 or higher of NTs. Median time to onset was 8 days and median duration was 7.5 days

NT-related clinical trial details (N=769)1

  • NTs resolved in 88% of cases with a median duration of 7.5 (range: 1-119) days
  • 83% of patients with NT also developed CRS
  • The most common NTs (≥5%) included encephalopathy, tremor, aphasia, delirium, and headache

Neurologic toxicities warnings and precautions1

  • NTs 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
  • Monitor patients daily for at least 7 days following Breyanzi infusion for signs and symptoms of neurologic toxicities and assess for other causes of neurological symptoms. Continue to monitor patients for signs or symptoms of neurologic toxicities for at least 2 weeks after infusion and treat promptly. Manage neurologic toxicity with supportive care and/or corticosteroid as needed
  • Counsel patients to seek immediate medical attention should signs or symptoms of NT occur at any time

Breyanzi offers the flexibility of inpatient or outpatient administration for appropriate patients1

MZL Cohort of TRANSCEND FL trial design (N=77): TRANSCEND FL was an open-label, multicenter, single-arm trial in adult patients. The MZL Cohort included patients with R/R MZL who received ≥2 prior lines of systemic therapy. The primary endpoint was ORR. In this trial 77 patients underwent leukapheresis, 67 patients were treated with Breyanzi, and 66 patients were included in the treated efficacy set.1

CRS, cytokine release syndrome; FL, follicular lymphoma; MZL, marginal zone lymphoma; NT, neurologic toxicity; ORR, overall response rate; R/R, relapsed or refractory.

Breyanzi was evaluated in 3L+ MZL in the MZL Cohort of TRANSCEND FL (N=67)1

The MZL Cohort of TRANSCEND FL was an open-label, single-arm study, which evaluated 67 adult patients with R/R MZL after 2 or more prior lines of therapy or relapsed after HSCT who received a single dose of CAR-positive viable T cells.

  • Serious adverse reactions occurred in 39% of patients. The most common nonlaboratory serious adverse reactions (>2%) were CRS, encephalopathy, aphasia, sepsis, tremor, delirium, dizziness, infusion-related hypersensitivity reaction, and transient ischemic attack. Fatal adverse reactions occurred in 3% of patients
  • The most common nonlaboratory adverse reactions (≥20%) were CRS, diarrhea, fatigue, musculoskeletal pain, and headache

In clinical trials of Breyanzi (N=769)1

  • Grade ≥3 infections occurred in 12% of all patients. Infections of any grade occurred in 33% of patients

Adverse reactions in ≥10% of patients treated with Breyanzi in MZL Cohort of TRANSCEND FL (N=67)1

Adverse reactions* Any grade (%) Grade ≥3 (%)
Gastrointestinal disorders    
Diarrhea 28 1.5
Nausea 18 1.5
Abdominal pain† 10 0
General disorders and administration site conditions    
Fatigue† 27 3
Endemaa 18 3
Fever† 10 0
Immune system disorders    
Cytokine release syndrome 76 4.5
Infections and infestations    
Infection with pathogen unspecified† 16 6
Metabolism and nutrition disorders    
Decreased appetite 10 3
Musculoskeletal and connective tissue disorders    
Musculoskeletal pain† 22 0
Nervous system disorders    
Headache 21 1.5
Tremor 21 0
Encephalopahtyb 21 1.5
Dizziness 16 0
Aphasia 10 0
Psychiatric disorders    
Deliriumc 10 3
Renal and urinary disorders    
Renal failure† 10 1.5
Vascular disorders    
Hypotension 10 0

*Includes adverse reactions up to 90 days following treatment with Breyanzi.1

†Represents multiple related terms.1

aEdema includes ascites, fluid retention, hypervolaemia, edema peripheral, peripheral swelling, pleural effusion, pulmonary edema.

bEncephalopathy includes brain fog, cognitive disorder, confusional state, disturbance in attention, dyscalculia, dysgraphia, memory impairment, somnolence.

cDelirium includes delirium, disorientation, hallucination, irritability, restlessness.

3L, third-line; CAR, chimeric antigen receptor; CRS, cytokine release syndrome; FL, follicular lymphoma; HSCT, hematopoietic stem cell transplantation; MZL, marginal zone lymphoma; NT, neurologic toxicity; R/R, relapsed or refractory.

References

  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2026.
  2. Kamdar M, Shadman M, Ahmed S, et al. Optimizing post-chimeric antigen receptor T cell monitoring: evidence across lisocabtagene maraleucel pivotal clinical trials and
real-world experience. Presented at: American Society of Clinical Oncology Annual Meeting; May 30-June 3, 2025; Chicago, IL. Poster 7026.
  3. Data on file. BMS-REF-LIS-0070. Princeton, NJ: Bristol-Myers Squibb Company: 2024.
References

Important Safety Information

Indication

BREYANZI is a CD19-directed genetically modified autologous T cell immunotherapy 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.

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 769 patients with non-Hodgkin lymphoma (NHL), CRS occurred in 56% of patients, including ≥ Grade 3 CRS 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%) were fever, hypotension, chills, tachycardia, 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 32% 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 7.5 days (range: 1 to 119 days). Of patients developing neurotoxicity, 83% also developed CRS.

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

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 33% 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 3.5%, 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 9% 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. Seven out of 769 (0.9%) patients with R/R NHL exposed to BREYANZI developed IEC-HS. Time to onset of IEC-HS ranged from 7 to 32 days. Of the 7 patients, 3 patients developed IEC-HS with overlapping occurrence of CRS and neurotoxicity, 2 patients developed IEC-HS with overlapping occurrence of neurotoxicity, and 1 patient developed IEC-HS with overlapping occurrence of CRS. IEC-HS was fatal in 2 of 7 patients. One patient had fatal IEC-HS and one had ongoing IEC-HS at time of death. 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:

  • MZL is CRS. The most common Grade 3-4 laboratory abnormalities include lymphocyte count decrease, neutrophil count decrease, and white blood cell decrease.

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

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