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Idecabtagene Vicleucel FDA Approved for Relapsed/Refractory Multiple Myeloma

Multiple myeloma.

The FDA has approved idecabtagene vicleucel (Abecma®, Bristol Myers Squibb) for patients with relapsed or refractory multiple myeloma who have already been treated with four or more lines of therapy, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.

"Idecabtagene vicleucel (ide-cel, also called bb2121), a B-cell maturation antigen-directed chimeric antigen receptor (CAR) T-cell therapy, has shown clinical activity with expected CAR T-cell toxic effects in patients with relapsed and refractory multiple myeloma," wrote Nikhil Munshi, MD, of the Dana-Farber Cancer Institute, and colleagues, in the February publication of the results of the phase 2 KarMMa trial (NCT03361748), on which the approval was based. "In this phase 2 study, we sought to confirm the efficacy and safety of ide-cel in patients with relapsed and refractory myeloma."

Safety and efficacy for the approval were evaluated in 127 patients with multiple myeloma who had been treated previously with at least three regimens, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody. Of these patients, 100 were treated with the dose range of 300 to 460 x 106 CAR-positive T cells. The primary endpoint was overall response rate, and secondary endpoints were complete response and duration of response.

Patients who had been treated with 300 to 460 X 106 CAR positive T cells had an objective response rate of 72%. The complete response rate was 28%, and the duration of response for 65% of patients who had a complete response was at least 12 months.

The most common adverse events as per the prescribing information are cytokine release syndrome, infections, fatigue, musculoskeletal pain, hypogammaglobulinemia, diarrhea, upper respiratory tract infection, nausea, viral infection, encephalopathy, edema, pyrexia, cough, headache, and decreased appetite.

"Ide-cel induced responses in a majority of heavily pretreated patients with refractory and relapsed myeloma; minimal residual disease-negative status was achieved in 26% of treated patients," concluded Dr. Munshi and colleagues in the New England Journal of Medicine publication. "Almost all patients had grade 3 or 4 toxic effects, most commonly hematologic toxic effects and cytokine release syndrome."

The recommended dose range for idecabtagene vicleucel is 300 to 460 x 106 CAR-positive T cells.

For More Information

Munshi NC, Anderson LD Jr, Shah N, et al (2021). Idecabtagene vicleucel in relapsed and refractory multiple myeloma. N Engl J Med, 384(8):705-716. DOI:10.1056/NEJMoa2024850

Clinicaltrials.gov (2020). Efficacy and safety study of bb2121 in subjects with relapsed and refractory multiple myeloma (KarMMa). NLM identifier: NCT 03361748.

Abecma® (idecabtagene vicleucel) prescribing information (2021). Bristol-Myers Squibb. Available at: https://www.fda.gov/media/147055/download

US Food & Drug Administration (2021). FDA approves idecabtagene vicleucel for multiple myeloma. Available at: https://www.fda.gov/drugs/drug-approvals-and-databases/fda-approves-idecabtagene-vicleucel-multiple-myeloma

Image credit: Nephron. Licensed under CC BY-SA 3.0


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