Safety

Breyanzi® delivers a safety profile you can count on in a broad range of patients across trials1

Breyanzi was evaluated in 2L in TRANSFORM (N=89) and PILOT (N=61) and in 3L+ in TRANSCEND (N=268)1
Majority of CRS events were low grade and most resolved quickly1
In clinical trials of Breyanzi (N=702), 54% of patients experienced any grade CRS and 3.2% of patients experienced Grade ≥3 CRS. Median time to onset of CRS was 5 (range 1-63) days; median duration was 5 (range 1-37) days.1
Graphic showing percentage of patients who experienced Any Grade CRS in the TRANSFORM, PILOT, and TRANSCEND trials Graphic showing percentage of patients who experienced Any Grade CRS in the TRANSFORM, PILOT, and TRANSCEND trials
Prophylactic corticosteroids were not used in Breyanzi trials.1
The majority of patients in 2L trials did not experience CRS of any grade1
No Grade 4 or 5 CRS events were reported in 2L trials2
In clinical trials of Breyanzi (N=702), one patient had fatal CRS and 5 patients had ongoing CRS at the time of death.1
Of the patients who received Breyanzi for LBCL2:
  • 23% received tocilizumab and/or a corticosteroid for CRS
  • 10% received tocilizumab only
  • 0% received corticosteroids only
Use of tocilizumab + corticosteroids were low.
Most common manifestations of CRS (≥10%) in clinical trials of Breyanzi (N=702)1
The most common manifestations of CRS (≥10%) included fever, hypotension, chills, tachycardia, hypoxia, and headache.
CRS 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 at a REMS-certified healthcare facility for signs and symptoms of CRS. Monitor patients for signs or symptoms of CRS for at least 4 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
2L, second-line; 3L, third-line; CRS, cytokine release syndrome; LBCL, large B-cell lymphoma; REMS, Risk Evaluation and Mitigation Strategy.
Majority of NT events were low grade and most resolved quickly1
In clinical trials of Breyanzi (N=702), 31% experienced NT and 10% of patients experienced Grade ≥3 NT. Median time to onset for NT was 8 (range 1-63) days; median duration was 7 (range 1-119) days.1
Graphic showing percentage of patients who experienced Any Grade NT in the TRANSFORM, PILOT, and TRANSCEND trials Graphic showing percentage of patients who experienced Any Grade NT in the TRANSFORM, PILOT, and TRANSCEND trials
The majority of patients in 2L did not experience NT events of any grade1
No Grade 4 or 5 NT events were reported in 2L trials2
NT 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, have also occurred
  • Monitor patients daily at least for at least 7 days following Breyanzi infusion at a REMS-certified healthcare facility for signs and symptoms of neurologic toxicities and assess for other causes of neurological symptoms. Monitor patients for signs or symptoms of neurologic toxicities for at least 4 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 neurologic toxicity occur at any time
Most common NTs (≥5%) in clinical trials of Breyanzi (N=702)1
The most common neurologic toxicities (≥5%) included encephalopathy, tremor, aphasia, delirium, and headache.
2L, second-line; NT, neurologic toxicity; REMS, Risk Evaluation and Mitigation Strategy.
Breyanzi adverse reactions observed across trials1
Incidence and severity of AEs were consistent across LBCL clinical trials1
Adverse reactions
observed in at least 10% 		TRANSFORM Trial (N=89) PILOT Trial (N=61)
Any Grade (%) ≥Grade 3 (%) Any Grade (%) ≥Grade 3 (%)
Blood and lymphatic system disorders
Febrile neutropenia 10 10 - -
Cardiac disorders
Tachycardiaa,q 15 1.1 10 0
Gastrointestinal disorders
Nausea 24 0 25 1.6
Constipation 20 2.2 11 0
Diarrhea 18 0 15 0
Abdominal painb 13 2.2 - -
Vomiting 11 0 - -
General disorders and administration site conditions
Fever 55 3.4 38 1.6
Fatiguec,r 28 1.1 44 1.6
Edemad,s 13 0 20 0
Immune system disorders
Cytokine release syndrome 49 1.1 39 1.6
Infections and infestationse
Bacterial infectious disorders 12 6 10 3.3
Infections with pathogen unspecifiedt 12 6 13 4.9
Sepsisf 10 7 - -
Upper respiratory tract infectionu - - 13 0
Metabolism and nutrition disorders
Decreased appetite 15 0 13 1.6
Musculoskeletal and connective tissue disorders
Musculoskeletal paing,v 36 3.4 23 4.9
Nervous system disorders
Headacheh 34 6 11 1.6
Dizzinessi,x 20 1.1 16 1.6
Motor dysfunctionj 12 3.4 - -
Tremork,y 11 1.1 16 0
Encephalopathyw - - 23 4.9
Psychiatric disorders
Insomnial 15 0 11 0
Respiratory, thoracic, and mediastinal disorders
Coughm,z 11 0 18 0
Dyspneaaa - - 16 4.9
Skin and subcutaneous tissue disorders
Rashn 12 1.1 - -
Vascular disorders
Hypotensiono,bb 15 2.2 23 1.6
Hemorrhagep 12 0 - -
Hypertension - - 10 4.9
TRANSFORM
aTachycardia includes atrial flutter, sinus tachycardia, supraventricular tachycardia, tachycardia.
bAbdominal pain includes abdominal pain, abdominal pain lower, abdominal tenderness.
cFatigue includes asthenia, fatigue, malaise.
dEdema includes edema peripheral, localized edema, edema peripheral, pleural effusion swelling.
eInfections and infestations are grouped per high-level grouped term.
fSepsis includes bacteremia, bacterial sepsis, enterococcal bacteremia, Escherichia bacteremia, Klebsiella bacteremia, Klebsiella sepsis, sepsis, septic shock, staphylococcal bacteremia.
gMusculoskeletal pain includes arthralgia, back pain, bone pain, flank pain, musculoskeletal chest pain, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, pain in extremity.
hHeadache includes headache, migraine, migraine with aura.
iDizziness includes dizziness, dizziness postural, syncope, vertigo.
jMotor dysfunction includes fine motor skill dysfunction, muscle spasms, muscular weakness.21
kTremor includes resting tremor, tremor, essential tremor.
lInsomnia includes insomnia, sleep disorder.
mCough includes cough, productive cough.
nRash includes catheter site rash, dermatitis acneiform, dermatitis exfoliative generalized, erythema multiforme, rash, rash maculo-papular, rash pruritic.
oHypotension includes hypotension, orthostatic hypotension.
pHemorrhage includes conjunctival hemorrhage, cystitis hemorrhagic, epistaxis, gastrointestinal hemorrhage, hematoma, hematuria, retinal hemorrhage, vaginal hemorrhage.
PILOT
qTachycardia includes atrial fibrillation, sinus tachycardia, tachycardia.
rFatigue includes asthenia, fatigue, malaise.
sEdema includes edema peripheral, pleural effusion, swelling.
tGrouped per high-level grouped term.
uUpper respiratory tract infection includes nasal congestion, paranasal sinus hypersecretion, rhinitis, rhinorrhea, upper respiratory tract infection.
vMusculoskeletal pain includes arthralgia, back pain, bone pain, flank pain, musculoskeletal chest pain, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, osteoarthritis, pain in extremity, spinal pain.
wEncephalopathy includes amnesia, apraxia, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, dyscalculia, encephalopathy, lethargy, memory impairment, mental status changes, somnolence.
xDizziness includes dizziness, dizziness postural, syncope, vertigo.
yTremor includes resting tremor, tremor.
zCough includes cough, productive cough.
aaDyspnea includes acute respiratory distress syndrome, dyspnea, tachypnea, wheezing.
bbHypotension includes hypotension, orthostatic hypotension.
Adverse reactions
observed in at least 10% 		TRANSCEND Trial (N=268)
Any Grade (%) ≥Grade 3 (%)
Cardiac disorders
Tachycardiaa 25 0
Gastrointestinal disorders
Nausea 33 1.5
Diarrhea 26 0.4
Constipation 23 0
Abdominal painb 21 3.0
Vomiting 21 0.4
General disorders and administration site conditions
Fatiguec 48 3.4
Edemad 21 1.1
Fever 16 0
Chills 12 0
Immune system disorders
Cytokine release syndrome 46 4.1
Infections and infestationse
Infections with pathogen unspecifiedf 29 16
Bacterial infectiong 13 5
Upper respiratory tract infectionh 13 0.7
Viral infection 10 1.5
Metabolism and nutrition disorders
Decreased appetite 28 2.6
Musculoskeletal and connective tissue disorders
Musculoskeletal paini 37 2.2
Nervous system disorders
Headachej 30 1.1
Encephalopathyk 29 9
Dizzinessl 24 2.6
Tremorm 16 0
Peripheral neuropathyn 11 0
Aphasiao 10 2.2
Motor dysfunctionp 10 1.1
Psychiatric disorders
Insomniaq 14 0.4
Anxietyr 10 0
Deliriums 10 2.2
Renal and urinary disorders
Renal failuret 11 3.0
Respiratory, thoracic, and mediastinal disorders
Coughu 23 0
Dyspneav 16 2.6
Skin and subcutaneous tissue disorders
Rashw 13 0.4
Vascular disorders
Hypotensionx 26 3.4
Hypertension 14 4.5
Hemorrhagey 10 1.5
TRANSCEND
aTachycardia includes heart rate increased, sinus tachycardia, tachycardia.
bAbdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness.
cFatigue includes asthenia, fatigue, malaise.
dEdema includes edema, edema peripheral, fluid overload, fluid retention, generalized edema, hypervolemia, peripheral swelling, pulmonary congestion, pulmonary edema, swelling.
eInfections and infestations are grouped by pathogen type and selected clinical syndromes.
fInfections with pathogen unspecified contains febrile neutropenia (9%).
gBacterial infection includes infections by pathogen type plus appendicitis, diverticulitis, peritonitis, skin infection, tooth infection.
hUpper respiratory tract infections include nasopharyngitis, pharyngitis, rhinitis, rhinovirus infection, sinusitis, upper respiratory tract congestion, upper respiratory tract infection.
iMusculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, pain in extremity, spinal pain.
jHeadache includes headache, head discomfort, migraine, sinus headache.
kEncephalopathy includes amnesia, bradyphrenia, cognitive disorder, confusional state, depersonalization/derealization disorder, depressed level of consciousness, disturbance in attention, encephalopathy, flat affect, hypersomnia, incoherent, lethargy, leukoencephalopathy, loss of consciousness, memory impairment, mental impairment, mental status changes, somnolence.
lDizziness includes dizziness, presyncope, syncope, vertigo.
mTremor includes essential tremor, resting tremor, tremor.
nPeripheral neuropathy includes hyperesthesia, hypoesthesia, meralgia paresthetica, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, sciatica, sensory loss.
oAphasia includes aphasia, disorganized speech, dysarthria, dysphemia, dysphonia, slow speech, speech disorder.
pMotor dysfunction includes eyelid ptosis, motor dysfunction, muscle rigidity, muscle spasms, muscle spasticity, muscle tightness, muscle twitching, muscular weakness, myoclonus, myopathy.
qInsomnia includes insomnia, somnambulism.
rAnxiety includes anxiety, panic attack.
sDelirium includes agitation, delirium, delusion, disorientation, hallucination, ‘hallucination, visual’, irritability, restlessness.
tRenal failure includes acute kidney injury, blood creatinine increased, chronic kidney disease, renal failure, renal injury.
uCough includes cough, productive cough, upper-airway cough syndrome.
vDyspnea includes acute respiratory failure, dyspnea, dyspnea exertional, respiratory failure.
wRash includes erythema, dermatitis acneiform, perineal rash, rash, rash erythematous, rash macular, rash maculopapular, rash morbilliform, rash papular, rash pruritic, rash pustular.
xHypotension includes hypotension, orthostatic hypotension.
yHemorrhage includes catheter site hemorrhage, conjunctival hemorrhage, epistaxis, hematoma, hematuria, hemorrhage, hemorrhage intracranial, pulmonary hemorrhage, retinal hemorrhage, vaginal hemorrhage.
Most common adverse reactions across Breyanzi trials1
2L LBCL: TRANSFORM (N=89) and PILOT (N=61)1
The most common nonlaboratory, serious adverse reactions (>2%) were CRS, febrile neutropenia, pulmonary embolism, headache, muscular weakness, aphasia, confusional state, gastrointestinal hemorrhage, encephalopathy, sepsis, pneumonia, fever, hypotension, dizziness, delirium, COVID-19 infection, and musculoskeletal pain.1
The most common nonlaboratory, adverse reactions of any grade (≥20%) were CRS, musculoskeletal pain, headache, fatigue, nausea, fever, constipation, dizziness, encephalopathy, hypotension, edema, infections (pathogen unspecified), decreased appetite, diarrhea, tachycardia, cough, abdominal pain, and vomiting.1
Serious adverse reactions occurred in 38% of patients in TRANSFORM and 33% in PILOT.1
The safety data for Breyanzi evaluated at 33.9 months median follow-up in the TRANSFORM trial were consistent with that of the 6.2-month (median follow-up) analysis.2,4
In PILOT, Any Grade AEs were reported in 51% of patients after the 90-day post-treatment emergent period (Grade ≥3, 18%).5
  • Any Grade AEs were reported in 97% of patients within the treatment-emergent period (Grade ≥3, 79%)
3L LBCL: TRANSCEND (N=268)
The most common nonlaboratory, serious adverse reactions (>2%) were CRS, encephalopathy, sepsis, febrile neutropenia, aphasia, pneumonia, fever, hypotension, dizziness, and delirium.1
The most common nonlaboratory adverse reactions (≥20%) were fatigue, CRS, musculoskeletal pain, nausea, headache, encephalopathy, infections (pathogen unspecified), decreased appetite, diarrhea, hypotension, tachycardia, dizziness, cough, constipation, abdominal pain, vomiting, and edema.1
Serious adverse reactions occurred in 46% of patients. Fatal adverse reactions occurred in 4% of patients.1
  • Forty-two percent of patients (105/249) experienced Any Grade AEs after the 90-day post-treatment emergent period (Grade ≥3, 23% [57/249])6
  • Grade 3 or 4 laboratory abnormalities (≥10%) were lymphocyte count decreased, neutrophil count decreased, platelet count decreased, hemoglobin decreased, phosphate decreased, and fibrinogen decreased.1
2L, second-line; 3L, third-line; AE, adverse event; CRS, cytokine release syndrome; LBCL, large B-cell lymphoma.
Important Safety Information
LESS
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.
  • BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS.
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 at a REMS-certified healthcare facility for signs and symptoms of CRS and neurologic toxicities and assess for other causes of neurological symptoms. Monitor patients for signs and symptoms of CRS and neurologic toxicities for at least 4 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. Counsel patients to seek immediate medical attention should signs or symptoms of CRS or neurologic toxicity occur at any time.
BREYANZI REMS
Because of the risk of CRS and neurologic toxicities, BREYANZI is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the BREYANZI REMS. The required components of the BREYANZI REMS are:
  • Healthcare facilities that dispense and administer BREYANZI must be enrolled and comply with the REMS requirements.
  • Certified healthcare facilities must have on-site, immediate access to tocilizumab.
  • Ensure that a minimum of 2 doses of tocilizumab are available for each patient for infusion within 2 hours after BREYANZI infusion, if needed for treatment of CRS.
Further information is available at www.BreyanziREMS.com, or contact Bristol-Myers Squibb at 1-866-340-7332.
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.
Effects on Ability to Drive and Use Machines
Due to the potential for neurologic events, including altered mental status or seizures, patients receiving BREYANZI are at risk for developing altered or decreased consciousness or impaired coordination in the 8 weeks following BREYANZI administration. Advise patients to refrain from driving and engaging in hazardous occupations or activities, such as operating heavy or potentially dangerous machinery, for at least 8 weeks.
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.
References
  1. National Cancer Institute. CD19-targeted CAR T2 cells. NCI Drug Dictionary. https://www.cancer.gov/publications/dictionaries/cancer-drug/def/cd19-targeted-car-t2-cells?redirect=true. Accessed May 22, 2024.
  2. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2024.
  3. Kamdar M, Solomon S, Arnason J, et al. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022;399(10343):2294-2308. 
  4. Kamdar M, Solomon S, Arnason J, et al. Lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) with salvage chemotherapy (CT) followed by autologous stem cell transplantation (ASCT) as second-line (2L) treatment in patients (pts) with R/R large B-cell lymphoma (LBCL): 3-year follow-up (FU) from the randomized, phase 3 TRANSFORM study. Presented at: 66th American Society of Clinical Oncology Annual Meeting; May 21-June 4, 2024; Chicago, IL.
  5. Data on file. BMS-REF-LIS-0049. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
  6. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for B-Cell Lymphomas V.2.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed April 30, 2024. To view the most recent and complete version of the guideline, go online to NCCN.org.
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2024.
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2024.
  2. Abramson J, Solomon S, Arnason J, et al. Lisocabtagene maraleucel as second-line therapy for large B-cell lymphoma: primary analysis of the phase 3 TRANSFORM study. Blood. 2023;141(4):1675-1684.
  3. Sehgal A, Hoda D, Riedell PA, et al. Lisocabtagene maraleucel as second-line therapy in adults with relapsed or refractory large B-cell lymphoma who were not intended for haematopoietic stem cell transplantation (PILOT): an open-label, phase 2 study. Lancet Oncol. 2022;23(8):1066-1077.
  4. Chen AI, Maziarz RT. Can we truly define 'Fitness' for CAR-T therapy in large B cell lymphoma patients? Chin Clin Oncol. 2023. doi:10.21037/cco-23-78
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2024.
  2. Kamdar M, Solomon S, Arnason J, et al. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022;399(10343):2294-2308.
  3. Abramson J, Solomon S, Arnason J, et al. Lisocabtagene maraleucel as second line therapy for large B-cell lymphoma: primary analysis of the phase 3 TRANSFORM study. Blood. 2023;141(4):1675-1684.
  4. Kamdar M, Solomon S, Arnason J, et al. Lisocabtagene maraleucel (liso-cel) vs standard of care (SOC) with salvage chemotherapy (CT) followed by autologous stem cell transplantation (ASCT) as second-line (2L) treatment in patients (pts) with R/R large B-cell lymphoma (LBCL): 3-year follow-up (FU) from the randomized, phase 3 TRANSFORM study. Presented at: American Society of Clinical Oncology Annual Meeting; May 21-June 4, 2024; Chicago, IL.
  5. Data on file. BMS-LIS-0052. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
  1. Sehgal A, Hoda D, Riedell PA, et al. Lisocabtagene maraleucel as second-line therapy for R/R large B-cell lymphoma in patients not intended for hematopoietic stem cell transplant: final analysis of the phase 2 PILOT study. ASH 2023.
  2. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2023.
  3. Data on file. BMS-REF-LIS-0019. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2023.
  2. Data on file. TRANSCEND DOR. Princeton, NJ: Bristol-Myers Squibb Company; 2022.
  3. Abramson J, Palomba M, Gordon L, et al. Two-year follow-up of TRANSCEND NHL 001, a multicenter phase 1 study of lisocabtagene maraleucel in relapsed or refractory large B-cell lymphomas. Presented at the 63rd American Society of Hematology Annual Meeting & Exposition; December 11-14, 2021; Atlanta, GA.
  4. Abramson JS, Palomba ML, Gordon LI, et al. Lisocabtagene maraleucel for patients with relapsed or refractory large B-cell lymphomas (TRANSCEND NHL 001): a multicentre seamless design study. Lancet. 2020;396(10254):839-852.
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2024.
  2. Data on file. BMS-REF-LIS-0052. Princeton, NJ: Bristol-Myers Squibb Company; 2024.
  3. Kamdar M, et al. Lisocabtagene maraleucel versus standard of care with salvage chemotherapy followed by autologous stem cell transplantation as second-line treatment in patients with relapsed or refractory large B-cell lymphoma (TRANSFORM): results from an interim analysis of an open-label, randomised, phase 3 trial. Lancet. 2022;399(10343):2294-2308.
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