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*

Prolonged cytopenias†‡

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

Prolonged cytopenias†‡

  • Prolonged neutropenia rates: 41% grade ≥3 (n=52)
    • Median time to recovery was 1.9 months in 83% (n=43/52) of patients who recovered from grade 3 or 4 neutropenia after month 1
  • Prolonged thrombocytopenia rates: 49% grade ≥3 (n=62)
    • Median time to recovery was 2.1 months in 65% (n=40/62) of patients who recovered from grade 3 or 4 thrombocytopenia
  • 2 of 3 patients who underwent hematopoietic reconstitution due to prolonged cytopenia died
  • Monitor blood counts prior to and after ABECMA infusion. Manage cytopenia with myeloid growth factor and blood product transfusion support according to local institutional guidelines

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.

Not resolved by month 1 following ABECMA infusion.

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.

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