INDICATION

ABECMA (idecabtagene vicleucel) is a B-cell maturation antigen (BCMA)-directed genetically modified autologous T cell immunotherapy indicated for the treatment of adult patients with relapsed or refractory multiple myeloma after four or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

This website is best viewed using the horizontal display on your tablet device.

This website is best viewed using the vertical display on your mobile device.

A Demonstrated Safety Profile After a One-Time Infusion With ABECMA®1*

Most common adverse reactions

  • The most common nonlaboratory adverse reactions (incidence ≥20%) included CRS, infections—pathogen unspecified, fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infections, encephalopathy, edema, pyrexia, cough, headache, and decreased appetite
  • Serious adverse reactions occurred in 67% of patients. The most common nonlaboratory (≥5%) serious adverse reactions included CRS (18%), general physical health deterioration (10%), pneumonia (12%), infections—pathogen unspecified (19%), viral infections (9%), sepsis (7%), and febrile neutropenia (6%). Fatal adverse reactions occurred in 6%
  • The most common (≥10%) grade 3 or 4 nonlaboratory adverse reactions were febrile neutropenia (16%) and infections—pathogen unspecified (15%)

Summary of adverse reactions observed in at least 10% of patients treated with ABECMA in the KarMMa study

Data at primary analysis. Safety profile remained consistent with longer follow-up and no new safety signals were observed.

  Any Grade, % Grade 3 or Higher, %
 
150-450 × 106
CAR-positive T cells
(N=127)
150-450 × 106
CAR-positive T cells
(N=127)
Blood and lymphatic system disorders
Febrile neutropenia 16 16
Cardiac disorders
Tachycardiaa 19 0
Gastrointestinal disorders
Diarrhea 35 1.6
Nausea 29 0
Constipation 16 0
Vomiting 15 0
Oral painb 12 0
General disorders and administration site conditions
Fatiguec 45 3.1
Pyrexia 25 1.6
General physical health deterioration 11 10
Edemad 25 0
Chills 11 0
Immune system disorders
Cytokine release syndrome 85 9
Hypogammaglobulinemiae 41 0.8
Infections and infestationsf
Infections – Pathogen unspecified 51 15
Viral infections 27 9
Bacterial infections 15 3.9
Pneumoniag 17 9
Upper respiratory tract infectionh 34 1.6
Investigations
Weight decreased 13 1.6
Metabolism and nutrition disorders
Decreased appetitei 22 0.8
Musculoskeletal and connective tissue disorders
Musculoskeletal painj 45 3.1
Motor dysfunctionk 11 0
Nervous system disorders
Encephalopathyl 26 6
Headachem 23 0
Dizzinessn 17 0.8
Neuropathy peripheralo 17 0.8
Tremorp 10 0
Psychiatric disorders
Insomniaq 13 0
Anxietyr 12 0.8
Renal and urinary disorders
Renal failures 10 2.4
Respiratory, thoracic, and mediastinal disorders
Cought 23 0
Dyspneau 13 2.4
Skin and subcutaneous tissue disorders
Rashv 14 0.8
Xerosisw 11 0
Vascular disorders
Hypotensionx 17 0
Hypertension 11 3.1

View all

Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Febrile neutropenia
16 16
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Tachycardiaa
19 0
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Diarrhea
35 1.6
Nausea
29 0
Constipation
16 0
Vomiting
15 0
Oral painb
12 0
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Fatiguec
45 3.1
Pyrexia
25 1.6
General physical health deterioration
11 10
Edemad
25 0
Chills
11 0
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Cytokine release syndrome
85 9
Hypogammaglobulinemiae
41 0.8
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Infections — Pathogen unspecifiedf
51 15
Viral infections
27 9
Bacterial infections
15 3.9
Pneumoniag
17 9
Upper respiratory tract infectionh
34 1.6
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Weight decreased
13 1.6
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Decreased appetitei
22 0.8
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Musculoskeletal painj
45 3.1
Motor dysfunctionk
11 0
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Encephalopathyl
26 6
Headachem
23 0
Dizzinessn
17 0.8
Neuropathy peripheralo
17 0.8
Tremorp
10 0
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Insomniaq
13 0
Anxietyr
12 0.8
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Renal failures
10 2.4
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Cought
23 0
Dyspneau
13 2.4
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Rashv
14 0.8
Xerosisw
11 0
Any Grade, % Grade 3 or Higher, %
150-450 × 106
(N=127)
150-450 × 106
(N=127)
Hypotensionx
17 0
Hypertension
11 3.1

aTachycardia includes sinus tachycardia, tachycardia.

bOral pain includes oral pain, oropharyngeal pain, toothache.

cFatigue includes asthenia, fatigue, malaise.

dEdema includes edema, face edema, fluid overload, fluid retention, generalized edema, peripheral edema, peripheral swelling, scrotal swelling, swelling.

eHypogammaglobulinemia includes patients with adverse events (21%) of blood immunoglobulin G decreased, hypogammaglobulinemia, hypoglobulinemia; and/or patients with laboratory IgG levels below 500 mg/dL following ABECMA infusion (25%).

fInfections and infestations System Organ Class Adverse Events are grouped by pathogen type and selected clinical syndromes.

gPneumonia includes bronchopulmonary aspergillosis, lung infection, pneumonia, pneumonia aspiration, pneumonia cytomegaloviral, pneumonia pneumococcal, pneumonia pseudomonal. Pneumonias may also be included under pathogen categories.

hUpper respiratory tract infection includes laryngitis, nasopharyngitis, pharyngeal erythema, pharyngitis, respiratory tract congestion, respiratory tract infection, rhinitis, rhinovirus infection, sinusitis, upper respiratory tract infection, upper respiratory tract infection bacterial. Upper respiratory tract infections may also be included under pathogen categories.

iDecreased appetite includes decreased appetite, hypophagia.

jMusculoskeletal pain includes arthralgia, back pain, bone pain, musculoskeletal chest pain, musculoskeletal discomfort, musculoskeletal pain, musculoskeletal stiffness, myalgia, neck pain, spinal pain.

kMotor dysfunction includes dysphonia, eyelid ptosis, hypotonia, motor dysfunction, muscle spasms, muscular weakness, restless legs syndrome.

lEncephalopathy includes amnesia, bradyphrenia, cognitive disorder, confusional state, depressed level of consciousness, disturbance in attention, dyscalculia, dysgraphia, encephalopathy, lethargy, memory impairment, mental status changes, metabolic encephalopathy, somnolence, toxic encephalopathy.

mHeadache includes headache, head discomfort, sinus headache.

nDizziness includes dizziness, presyncope, syncope, vertigo.

oNeuropathy peripheral includes carpal tunnel syndrome, hypoesthesia, hypoesthesia oral, neuralgia, neuropathy peripheral, paresthesia, peripheral sensorimotor neuropathy, peripheral sensory neuropathy, sciatica.

pTremor includes asterixis, tremor.

qInsomnia includes insomnia, sleep deficit, sleep disorder.

rAnxiety includes anxiety, feeling jittery, nervousness.

sRenal failure includes acute kidney injury, blood creatinine increased, chronic kidney disease, renal failure, renal impairment.

tCough includes cough, productive cough, upper-airway cough syndrome.

uDyspnea includes acute respiratory failure, dyspnea, dyspnea exertional, respiratory failure.

vRash includes acne, dermatitis, dermatitis bullous, erythema, rash, rash macular, rash papular, urticaria.

wXerosis includes dry eye, dry mouth, dry skin, lip dry, xerosis.

xHypotension includes hypotension, orthostatic hypotension.

Grade 3 or 4 laboratory abnormalities worsening from baseline in at least 10% of patients treated with ABECMA in the KarMMa study

 
150-450 × 106
CAR-positive T cells
(N=127)
%
Neutropenia 96
Leukopenia 96
Lymphopenia 92
Thrombocytopenia 63
Anemia 63
Hypophosphatemia 45
Hyponatremia 10
aPTT increased (seconds) 10

Laboratory tests were graded according to NCI CTCAE Version 4.03. Laboratory abnormalities are sorted by decreasing frequency in the 150 to 450 × 106 column.

Treatment process includes leukapheresis, manufacturing, administration, and adverse event monitoring. A single dose of ABECMA contains a cell suspension of 300 to 460 x 106 CAR-positive T cells in one or more infusion bags.

aPTT=activated partial thromboplastin time; ARs=adverse reactions; CRS=cytokine release syndrome; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events

Identify your
ABECMA-eligible patients

Find a certified
treatment center near you