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 two or more prior lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

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Across registrational studies (N=349),1*

Neurologic Toxicity Predictability with ABECMA®

Early onset with rapid resolution

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  • Cerebral edema has been associated with ABECMA in a patient in another study in multiple myeloma1
  • Neurologic toxicities, which may be severe or life-threatening, including immune-effector cell-associated neurotoxicity (ICANS) occurred following treatment with ABECMA, including concurrently with CRS, after CRS resolution, or in the absence of CRS1

Pooled registrational studies included KarMMa-3 and KarMMa (5L+).1

The median duration of CAR T cell-associated neurologic toxicity was 8 days (range: 1 to 720 days) in all patients including those with ongoing neurologic events at the time of death or data cutoff.

No cases of parkinsonism or Guillain-Barré syndrome were observed across registrational studies.2*

Through September 2023, BMS safety reporting analysis notes that out of the 3243 cases seen with ABECMA, there were2-4§:

  • 5 cases of parkinsonism
  • 0 cases of Guillain-Barré syndrome

Grade 3 myelitis and grade 3 parkinsonism have occurred after treatment with ABECMA in another study in multiple myeloma. National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) criteria (version 4.03) utilized for grading neurologic toxicities.1

Of the 3243, patients span clinical trials (744) and real-world safety reporting on commercial product (2622). Identification of adverse events in real-world setting is dependent on physician reporting and grading perspectives. Post-marketing surveillance is voluntary.2

Neurologic toxicity monitoring and management1

  • Counsel patients to seek immediate medical attention should signs or symptoms of neurologic toxicities 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 neurologic toxicities
    • 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 signs or symptoms
  • Treat promptly with supportive care and/or corticosteroids as needed based on the grading and management guidelines
    • If neurologic toxicity is suspected, manage according to the recommendations in the full Prescribing Information
    • If concurrent CRS is suspected during the neurologic toxicity 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

CAR=chimeric antigen receptor; CRS=cytokine release syndrome; NCI CTCAE=National Cancer Institute Common Terminology Criteria for Adverse Events.

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