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.

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

CRS was generally predictable in KarMMa—most were low grade, with early onset and resolution1,2†

CRS rates

150-450 × 106 CAR-positive T cells (N=127)

Median time to onset


Range: 1-23 days

Median duration


Range: 1-63 days

9% Grade ≥3 (n=12)

85% All grades (n=108)

46% Grade 1 (n=58) /
30% Grade 2 (n=38) /
Grade 5 CRS was reported in one (0.8%) patient.

CRS, including fatal or life-threatening reactions, occurred following treatment with ABECMA.

Manifestations of CRS1

Most common manifestations of CRS (N=127)


Grade 3 or higher events that may be associated with CRS

Grade 3 or higher events that may be associated with CRS include hypotension, hypoxia, hyperbilirubinemia, hypofibrinogenemia, ARDS, atrial fibrillation, hepatocellular injury, metabolic acidosis, pulmonary edema, multiple organ dysfunction syndrome, and HLH/MAS.

Monitoring and management1

  • Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time
  • Instruct patients to remain within proximity of the certified healthcare facility for at least 4 weeks following infusion
  • Monitor patients for signs and symptoms of CRS
    • At least daily for 7 days at the certified healthcare facility following ABECMA infusion
    • For at least 4 weeks after ABECMA infusion
  • Treat at the first sign of CRS with supportive care, tocilizumab, and/or corticosteroids as needed based on the grading and management guidelines
    • If CRS is suspected, manage according to the recommendations in the full Prescribing Information
    • If concurrent CRS is suspected during an NT event, manage CRS according to the recommendations in the full Prescribing Information
  • Ensure that a minimum of 2 doses of tocilizumab per patient are available prior to infusion of ABECMA

CRS treatment1

  • Treat at the first sign of CRS with supportive care, tocilizumab and/or corticosteroids as indicated
  • Identify CRS based on clinical presentation. Evaluate for and treat other causes of fever, hypoxia, and hypotension
  • CRS has been reported to be associated with findings of HLH/MAS, and the physiology of the syndromes may overlap
    • In patients with progressive symptoms of CRS or refractory CRS despite treatment, evaluate for evidence of HLH/MAS
  • 54% (68/127) of patients received tocilizumab
    • 35% (45/127) received a single dose
    • 18% (23/127) received more than 1 dose
  • Overall, 15% (19/127) of patients received at least 1 dose of corticosteroids for treatment of CRS
    • All patients that received corticosteroids for CRS also received tocilizumab

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.

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

Lee criterial for grading CRS (Lee et al, 2014)

ARs=adverse reactions; ARDS=acute respiratory distress syndrome; CAR=chimeric antigen receptor; CRS=cytokine release syndrome; HLH/MAS=hemophagocytic lymphohistiocytosis/macrophage activation syndrome; NT=neurologic toxicity.

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