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.

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

HLH/MAS1†

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

HLH/MAS1†

  • HLH/MAS rates: 4% all grades (n=5)
  • One grade 5 HLH/MAS was observed. In another patient with fatal bronchopulmonary aspergillosis, HLH/MAS was contributory to the fatal outcome
  • Median time to onset: 7 days (range: 4-9 days)
  • HLH/MAS is a potentially life-threatening condition with a high mortality rate if not recognized early and treated. Treatment of HLH/MAS should be administered per institutional standards

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.

ARs=adverse reactions; CAR=chimeric antigen receptor; HLH/MAS=hemophagocytic lymphohistiocytosis/macrophage activation syndrome.

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