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*

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

NT rates

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

Median time to onset


Range: 1-42 days

Median duration


In 33 of 36 patients
who had resolved NT

Range: 1-61 days

In 33 of 36 patients
who had resolved NT

4% Grade 3 (n=5)

28% All grades (n=36)



All grades

17% Grade 1 (n=21) /
8% Grade 2 (n=10) /
There were no grade 4 or 5 NT events in KarMMa.

*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.

For patients who experienced NT, including 3 patients with ongoing NT, the median duration of CAR T cell-associated NT was 6 days (range: 1 to 578 days).

Neurologic toxicities, which may be severe or life-threatening, occurred following treatment with ABECMA, including concurrently with CRS (n=34), with onset during CRS (n=29), before CRS (n=3), after CRS resolution (n=2), or in the absence of CRS.

In KarMMa, no grade 3 or higher parkinsonian or motor symptoms were observed.

Grade 3 myelitis and Grade 3 parkinsonism have occurred after treatment with ABECMA in another study in multiple myeloma. NCI CTCAE criteria (version 4.03) utilized for grading neurologic toxicities.

Manifestations of NT1†

Most common (≥5%) manifestations of NT (N=127)

Encephalopathy 20%
Tremor 9%
Aphasia 7%
Delirium 6%

Monitoring and management1

  • Counsel patients to seek immediate medical attention should signs or symptoms of NT 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 NT
    • At least daily for 7 days at the certified healthcare facility following ABECMA infusion
    • For at least 4 weeks after ABECMA infusion
  • Exclude other causes of neurologic symptoms
  • Treat promptly with supportive care and/or corticosteroids as needed based on the grading and management guidelines
    • If NT is suspected, manage according to the recommendations in the full Prescribing Information
    • If concurrent CRS is suspected during the NT event, manage CRS according to the recommendations in the full Prescribing Information
    • Patients with any-grade neurologic toxicity should be treated with non-sedating antiseizure medicine for seizure prophylaxis

ARs=adverse reactions; CAR=chimeric antigen receptor; CRS=cytokine release syndrome; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events; NT=neurologic toxicity.

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