Breyanzi® has established safety and tolerability 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
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:
Limitations of Use: BREYANZI is not indicated for the treatment of patients with primary central nervous system lymphoma.
Safety
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,cc | 15 | 1.1 | 10 | - |
Gastrointestinal disorders | ||||
Nausea | 24 | 0 | 25 | 1.6 |
Constipation | 20 | 2.2 | 11 | 0 |
Diarrhea | 18 | 0 | 15 | 0 |
Abdominal painb,dd | 13 | 2.2 | - | - |
Vomiting | 11 | 0 | - | - |
General disorders and administration site conditions | ||||
Fever | 55 | 3.4 | 38 | 1.6 |
Fatiguec,r,ee | 28 | 1.1 | 44 | 2 |
Edemad,s,ff | 13 | 0 | 20 | - |
Chills | - | - | - | - |
Immune system disorders | ||||
Cytokine release syndrome | 49 | 1.1 | 39 | 1.6 |
Infections and infestationse,gg | ||||
Bacterial infectious disorders | 12 | 6 | 10 | 3.3 |
Infections—pathogen unspecifiedt,hh | 12 | 6 | 13 | 4.9 |
Sepsisf | 10 | 7 | - | - |
Bacterial infection | - | - | - | - |
Upper respiratory tract infection | - | - | - | - |
Viral infection | - | - | - | - |
Metabolism and nutrition disorders | ||||
Decreased appetite | 15 | 0 | 13 | 1.6 |
Musculoskeletal and connective tissue disorders | ||||
Musculoskeletal pain g,v,kk | 36 | 3.4 | 23 | 4.9 |
Motor dysfunctionh,ll | 12 | 3.4 | - | - |
Nervous system disorders | ||||
Headachei,mm | 34 | 6 | 11 | 1.6 |
Dizzinessj,x,oo | 20 | 1.1 | 16 | 1.6 |
Tremork,y,pp | 11 | 1.1 | 16 | 0 |
Encephalopathyw,nn | - | - | 23 | 4.9 |
Peripheral neuropathyqq | - | - | - | - |
Aphasiarr | - | - | - | - |
Psychiatric disorders | ||||
Insomnial,ss | 15 | 0 | 11 | 0 |
Anxietytt | - | - | - | - |
Deliriumuu | - | - | - | - |
Renal and urinary disorders | ||||
Renal failurevv | - | - | - | - |
Respiratory, thoracic, and mediastinal disorders | ||||
Coughm,z,ww | 11 | 0 | 18 | 0 |
Dyspneaaa,xx | - | - | 16 | 4.9 |
Skin and subcutaneous tissue disorders | ||||
Rashn,yy | 12 | 1.1 | - | - |
Vascular disorders | ||||
Hypotensiono,bb,zz | 15 | 2.2 | 23 | 1.6 |
Hemorrhagep,aaa | 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. hMotor dysfunction includes fine motor skill dysfunction, muscle spasms, muscular weakness. iHeadache includes headache, migraine, migraine with aura. jDizziness includes dizziness, dizziness postural, syncope, vertigo. 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. |
||||
TRANSCEND ccTachycardia includes heart rate increased, sinus tachycardia, tachycardia. ddAbdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness. eeFatigue includes asthenia, fatigue, malaise. ffEdema includes edema, edema peripheral, fluid overload, fluid retention, generalized edema, hypervolemia, peripheral swelling, pulmonary congestion, pulmonary edema, swelling. ggInfections and infestations are grouped by pathogen type and selected clinical syndromes. hhInfections with pathogen unspecified contains febrile neutropenia (9%). iiBacterial infection includes infections by pathogen type plus appendicitis, diverticulitis, peritonitis, skin infection, tooth infection. jj Upper respiratory tract infections include nasopharyngitis, pharyngitis, rhinitis, rhinovirus infection, sinusitis, upper respiratory tract congestion, upper respiratory tract infection. kkMusculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, pain in extremity, spinal pain. llMotor dysfunction includes eyelid ptosis, motor dysfunction, muscle rigidity, muscle spasms, muscle spasticity, muscle tightness, muscle twitching, muscular weakness, myoclonus, myopathy. mmHeadache includes headache, head discomfort, migraine, sinus headache. nnEncephalopathy 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. ooDizziness includes dizziness, presyncope, syncope, vertigo. pTremor includes essential tremor, resting tremor, tremor. rPeripheral neuropathy includes hyperesthesia, hypoesthesia, meralgia paresthetica, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, sciatica, sensory loss. rAphasia includes aphasia, disorganized speech, dysarthria, dysphemia, dysphonia, slow speech, speech disorder. sInsomnia includes insomnia, somnambulism. tAnxiety includes anxiety, panic attack. uDelirium includes agitation, delirium, delusion, disorientation, hallucination, ‘hallucination, visual’, irritability, restlessness. vRenal failure includes acute kidney injury, blood creatinine increased, chronic kidney disease, renal failure, renal injury. wCough includes cough, productive cough, upper-airway cough syndrome. xDyspnea includes acute respiratory failure, dyspnea, dyspnea exertional, respiratory failure. yRash includes erythema, dermatitis acneiform, perineal rash, rash, rash erythematous, rash macular, rash maculo-papular, rash morbilliform, rash papular, rash pruritic, rash pustular. zHypotension includes hypotension, orthostatic hypotension. aaaHemorrhage includes catheter site hemorrhage, conjunctival hemorrhage, epistaxis, hematoma, hematuria, hemorrhage, hemorrhage intracranial, pulmonary hemorrhage, retinal hemorrhage, vaginal hemorrhage. |
Adverse Reactions Observed in at Least 10% | TRANSCEND Trial (N=268) | |
---|---|---|
Any Grade (%) | ≥Grade 3 (%) |
Blood and lymphatic system disorders | |||
Febrile neutropenia | - | - | |
Cardiac disorders | |||
Tachycardiaa,q,c | 25 | 0 | |
Gastrointestinal disorders | |||
Nausea | 33 | 1.5 | |
Constipation | 23 | 0 | |
Abdominal painb,dd | 26 | 0.4 | |
Diarrhea | 21 | 3.0 | |
Vomiting | 21 | 0.4 | |
General disorders and administration site conditions | |||
Fever | 16 | 0 | |
Fatiguec,r,ee | 48 | 3.4 | |
Edemad,s,ff | 21 | 1.1 | |
Chills | 12 | 0 | |
Immune system disorders | |||
Cytokine release syndrome | 46 | 4.1 | |
Hypogammaglobulinemiae | - | - | |
Infections and infestationse,gg | |||
Bacterial infectious disorders | - | - | |
Infections—pathogen unspecifiedt,hh | 29 | 16 | |
Sepsisf | - | - | |
Bacterial infection | 13 | 5 | |
Upper respiratory tract infection | 13 | 0.7 | |
Viral infection | 10 | 1.5 | |
Metabolism and nutrition disorders | |||
Decreased appetite | 28 | 2.6 | |
Musculoskeletal and connective tissue disorders | |||
Musculoskeletal paing,v,kk | 37 | 2.2 | |
Motor dysfunctionh,ll | 10 | 1.1 | |
Nervous system disorders | |||
Headachei,mm | 30 | 1.1 | |
Dizzinessj,x,oo | 24 | 2.6 | |
Tremork,y,pp | 16 | 0 | |
Encephalopathyw,nn | 29 | 9 | |
Peripheral neuropathyqq | 11 | 0 | |
Aphasiarr | 10 | 2.2 | |
Psychiatric disorders | |||
Insomnial,ss | 14 | 0.4 | |
Anxietytt | 10 | 0 | |
Deliriumuu | 10 | 2.2 | |
Renal and urinary disorders | |||
Renal failurevv | 11 | 3.0 | |
Respiratory, thoracic, and mediastinal disorders | |||
Cough m,z,ww | 23 | 0 | |
Dyspneaa,xx | 16 | 2.6 | |
Skin and subcutaneous tissue disorders | |||
Rashn,yy | 13 | 0.4 | |
Vascular disorders | |||
Hypotensiono,bb,zz | 26 | 3.4 | |
Hemorrhagep,aaa | 14 | 4.5 | |
Hypertension | 10 | 1.5 | |
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. hMotor dysfunction includes fine motor skill dysfunction, muscle spasms, muscular weakness. iHeadache includes headache, migraine, migraine with aura. jDizziness includes dizziness, dizziness postural, syncope, vertigo. 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. |
|||
TRANSCEND ccTachycardia includes heart rate increased, sinus tachycardia, tachycardia. ddAbdominal pain includes abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness. eeFatigue includes asthenia, fatigue, malaise. ffEdema includes edema, edema peripheral, fluid overload, fluid retention, generalized edema, hypervolemia, peripheral swelling, pulmonary congestion, pulmonary edema, swelling. ggInfections and infestations are grouped by pathogen type and selected clinical syndromes. hhInfections with pathogen unspecified contains febrile neutropenia (9%). iiBacterial infection includes infections by pathogen type plus appendicitis, diverticulitis, peritonitis, skin infection, tooth infection. jj Upper respiratory tract infections include nasopharyngitis, pharyngitis, rhinitis, rhinovirus infection, sinusitis, upper respiratory tract congestion, upper respiratory tract infection. kkMusculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, pain in extremity, spinal pain. llMotor dysfunction includes eyelid ptosis, motor dysfunction, muscle rigidity, muscle spasms, muscle spasticity, muscle tightness, muscle twitching, muscular weakness, myoclonus, myopathy. mmHeadache includes headache, head discomfort, migraine, sinus headache. nnEncephalopathy 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. ooDizziness includes dizziness, presyncope, syncope, vertigo. pTremor includes essential tremor, resting tremor, tremor. rPeripheral neuropathy includes hyperesthesia, hypoesthesia, meralgia paresthetica, neuralgia, neuropathy peripheral, paresthesia, peripheral sensory neuropathy, sciatica, sensory loss. rAphasia includes aphasia, disorganized speech, dysarthria, dysphemia, dysphonia, slow speech, speech disorder. sInsomnia includes insomnia, somnambulism. tAnxiety includes anxiety, panic attack. uDelirium includes agitation, delirium, delusion, disorientation, hallucination, ‘hallucination, visual’, irritability, restlessness. vRenal failure includes acute kidney injury, blood creatinine increased, chronic kidney disease, renal failure, renal injury. wCough includes cough, productive cough, upper-airway cough syndrome. xDyspnea includes acute respiratory failure, dyspnea, dyspnea exertional, respiratory failure. yRash includes erythema, dermatitis acneiform, perineal rash, rash, rash erythematous, rash macular, rash maculo-papular, rash morbilliform, rash papular, rash pruritic, rash pustular. zHypotension includes hypotension, orthostatic hypotension. aaaHemorrhage includes catheter site hemorrhage, conjunctival hemorrhage, epistaxis, hematoma, hematuria, hemorrhage, hemorrhage intracranial, pulmonary hemorrhage, retinal hemorrhage, vaginal hemorrhage. |
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