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FDA Approves Bristol Myers Squibb, Bluebird Bio's Multiple Myeloma CAR T-Cell Therapy Abecma

NEW YORK – The US Food and Drug Administration on Friday approved Bristol Myers Squibb and Bluebird Bio's CAR T-cell therapy, idecabtagene vicleucel (Abecma), for patients with relapsed or refractory multiple myeloma who have previously received at least four lines of treatment, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.

Idecabtagene vicleucel, or ide-cel, is an autologous CAR T-cell therapy engineered to target the B-cell maturation antigen (BCMA) protein expressed on multiple myeloma cells. The FDA based its approval on data from 127 multiple myeloma patients treated in the Phase II KarMMa trial. The overall response rate among the 100 efficacy-evaluable patients in this group was 72 percent, and the complete response rate was 28 percent. After a year, an estimated 65 percent of the patients who had a complete response remained in complete response. Overall, the median duration of response was 11 months.

In terms of safety, 85 percent of the 127 patients experienced cytokine release syndrome (CRS) of any grade, and 9 percent experienced CRS grade 3 or higher. Neurotoxicity occurred in 28 percent of patients, and 4 percent experienced neurotoxicity of grade 3 or higher. The FDA is requiring BMS and Bluebird to conduct a postmarket observational study to further evaluate the treatment's safety.

Ide-cel marks the first FDA approval for an anti-BCMA CAR T-cell therapy for multiple myeloma. This is the second approval for an autologous CAR T-cell therapy that BMS has received; in February, the agency approved BMS' lisocabtagene maraleucel (Breyanzi) as a treatment for relapsed or refractory large B-cell lymphoma.