The safety profile for Breyanzi® in R/R CLL and SLL builds on evidence seen in clinical trials and other lymphoma indications1

The primary safety analysis was conducted in the full safety set (N=702), which included all patients who received a single dose of CAR positive viable T cells.

The planned dose of BREYANZI was 100 × 106 CAR-positive viable T cells.

CRS events were primarily low-grade1
Rates of cytokine release syndrome (CRS) in patients of Breyanzi Transcend CLL 004 clinical trial Rates of cytokine release syndrome (CRS) in patients of Breyanzi Transcend CLL 004 clinical trial
CRS-related clinical trial details1
  • 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
Most common manifestations of CRS1
Among patients with CRS, the most common manifestations (≥10%) included fever, hypotension, chills, tachycardia, hypoxia, and headache.
Cytokine release syndrome warnings and precautions1
  • CRS, including 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 at a REMS-certified healthcare facility following infusion 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
CAR, chimeric antigen receptor; CLL, chronic lymphocytic leukemia; CRS, cytokine release syndrome; NT, neurologic toxicity; R/R, relapsed or refractory; SLL, small lymphocytic lymphoma.
NT events were primarily low-grade1
Rates of neurologic toxicities (NT) in patients of Breyanzi Transcend CLL 004 clinical trial Rates of neurologic toxicities (NT) in patients of Breyanzi Transcend CLL 004 clinical trial
Neurologic toxicity–related clinical trial details1
  • Median time to NT onset 8 days (range: 1 to 63 days)
  • Neurologic toxicities resolved in 88% of cases with a median duration of 7 days (range: 1 to 119 days)
  • 82% of patients with neurologic toxicity developed CRS
Most common neurologic toxicities1
Encephalopathy, tremor, aphasia, delirium, and headache
Neurologic toxicity warnings and precautions1
  • 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
  • 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
NT, neurologic toxicity.
Most common adverse reactions observed in TRANSCEND CLL 0041
  • Serious adverse reactions occurred in 60% of patients
  • The most common nonlaboratory serious adverse reactions (≥2%) were CRS, encephalopathy, febrile neutropenia, pneumonia, hemorrhage, fever, renal failure, aphasia, abdominal pain, delirium, tumor lysis syndrome, upper respiratory tract infection, and hemophagocytic lymphohistiocytosis [IEC-HS]. Fatal adverse reactions occurred in 1.1% of patients
  • The most common nonlaboratory adverse reactions (≥20%) were CRS, encephalopathy, fatigue, musculoskeletal pain, nausea, headache, diarrhea, fever, edema, dizziness, coagulopathy, decreased appetite, constipation, dyspnea, tremor, abdominal pain, transaminase elevation, infections (pathogen unspecified), renal failure, cough, delirium
This table includes adverse reactions observed in ≥10% of the full population (N=89) treated with Breyanzi1
Adverse reactions Any Grade (%) Grade 3 or higher (%)
Blood and lymphatic system disorders
Febrile neutropenia 12 12
Cardiac disorders
Tachycardiaa 21 0
Gastrointestinal disorders
Nausea 35 0
Diarrheab 30 1.1
Constipation 24 0
Abdominal painc 18 0
Vomiting 15 0
General disorders and administration site conditions
Fatigued 40 4.5
Edemae 30 4.5
Feverf 27 1.1
Chills 17 1.1
Immune system disorders
Cytokine release syndrome 83 9
Infections and infestations
Infection with pathogen unspecifiedg 23 10
Upper respiratory tract infectionh 19 1.1
Viral infectiong 10 1.1
Metabolism and nutrition disorders
Decreased appetite 27 4.5
Tumor lysis syndrome 11 11
Musculoskeletal and connective tissue disorders
Musculoskeletal paini 42 1.1
Nervous system disorders
Encephalopathyj 44 18
Headachek 28 1.1
Tremor 24 2.2
Dizzinessl 21 1.1
Motor dysfunctionm 14 2.2
Peripheral neuropathyn 12 0
Taste disordero 10 0
Psychiatric disorders
Deliriump 20 3.4
Insomnia 16 1.1
Anxiety 12 1.1
Renal and urinary disorders
Renal failureq 15 3.4
Respiratory, thoracic, and mediastinal disorders
Dyspnear 27 8
Coughs 20 0
Skin and subcutaneous tissue disorders
Rasht 23 2.2
Vascular disorders
Hypotensionu 17 0
Hemorrhagev 16 1.1
Hypertension 10 4.5
aTachycardia includes atrial fibrillation, atrial flutter, sinus tachycardia, tachycardia, ventricular tachycardia.
bDiarrhea includes diarrhea.
cAbdominal pain includes abdominal pain, abdominal tenderness.
dFatigue includes asthenia, fatigue, malaise.
eEdema includes ascites, face edema, hypervolemia, edema peripheral, pleural effusion, pulmonary edema, scrotal edema.
fFever includes pyrexia.
gGrouped per high-level grouped term.
hUpper respiratory tract infection includes acute sinusitis, nasal congestion, nasopharyngitis, rhinitis, rhinovirus infection, sinusitis, upper respiratory tract infection.
iMusculoskeletal pain includes arthralgia, arthritis, back pain, bone pain, flank pain, musculoskeletal chest pain, myalgia, neck pain, non-cardiac chest pain, pain in extremity.
jEncephalopathy includes cognitive disorder, confusional state, disturbance in attention, encephalopathy, lethargy, memory impairment, mental status changes, somnolence.
kHeadache includes headache, sinus headache.
lDizziness includes dizziness, presyncope, syncope, vertigo.
mMotor dysfunction includes asterixis, muscle spasms, muscular weakness, myoclonus.
nPeripheral neuropathy includes hyperaesthesia, hypoaesthesia, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy.
oTaste disorder includes dysgeusia, taste disorder.
pDelirium includes agitation, delirium, hallucination, hallucination visual, intensive care unit delirium, irritability, restlessness.
qRenal failure includes acute kidney injury, chronic kidney disease, renal failure.
rDyspnea includes dysponea, respiratory failure, tachypnoea, wheezing.
sCough includes cough, productive cough, upper-airway cough syndrome.
tRash includes dermatitis contact, erythema, petechiae, rash, rash macular, rash maculo-papular, scrotal erythema , seborrhoeic keratosis, urticaria.
uHypotension includes hypotension, orthostatic hypotension.
vHemorrhage includes epistaxis, haemorrhage intracranial, haematoma, haematuria, haemorrhoidal haemorrhage, intraventricular haemorrhage, lower gastrointestinal haemorrhage, traumatic haemothorax.
BCL-2i, B-cell lymphoma-2 inhibitor; BTKi, Bruton tyrosine kinase inhibitor; CAR, chimeric antigen receptor; CLL, chronic lymphocytic leukemia; CRS, cytokine release syndrome; NT, neurologic toxicity; R/R, relapsed or refractory; SLL, small lymphocytic lymphoma.

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Reference
  1. Breyanzi [package insert]. Summit, NJ: Bristol-Myers Squibb Company; 2024.