NEW YORK – The European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, on Friday recommended marketing authorization for Bristol Myers Squibb's CAR T-cell therapy idecabtagene vicleucel (Abecma) for heavily pretreated relapsed and refractory multiple myeloma patients.
Idecabtagene vicleucel, or ide-cel, is an autologous CAR T-cell therapy that targets the BCMA protein expressed on multiple myeloma cells. The committee based its opinion on data from the Phase II KarMMa study evaluating ide-cel in 128 patients with relapsed and refractory multiple myeloma who had received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody.
Also using data from KarMMa, which were published in February, the US Food and Drug Administration approved ide-cel in March for the same indication. In the study, 73 percent of multiple myeloma patients responded to ide-cel, and 33 percent had a complete response or better. Among patients who responded, 33 patients (79 percent) reached minimal residual disease-negative status. The median progression-free survival in the study was 8.8 months.
"As the first CAR T-cell therapy for relapsed and refractory multiple myeloma to receive a positive CHMP opinion, Abecma represents a potential new treatment approach for patients in Europe battling this incurable blood cancer," Noah Berkowitz, senior VP of cellular therapy development at BMS, said in a statement.
The European Commission will review the CHMP's opinion and is expected to issue a decision by the end of August. The EMA previously included ide-cel in its PRIority Medicines, or PRIME, scheme, which allows for accelerated assessment and other regulatory support to speed drug approvals.
In February, Janssen said that the CHMP would also conduct an accelerated assessment of its dual-binding BCMA-targeting CAR T-cell therapy, ciltacabtagene autoleucel (cilta-cel), for previously treated, relapsed or refractory multiple myeloma. The company had said at the time that it would submit a marketing authorization application for the drug to CHMP in the first half of 2021, and the data package would include data from the CARTITUDE-1 trial, in which 95 percent of relapsed or refractory multiple myeloma patients responded to the CAR T-cell treatment and 56 percent had a complete response.