The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) gave a positive recommendation for the Marketing Authorization approval of idecabtagene vicleucel (ide-cel), a BCMA-targeted monoclonal antibody developed by Bristol Myers Squibb.
Ide-cel is designed to treat adult patients with relapsed or refractory multiple myeloma after at least two prior lines of therapy, which includes an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 monoclonal antibody.
“This positive CHMP opinion represents an important step toward bringing our potentially transformative first-in-class anti-BCMA CAR T-cell therapy, Abecma, to more patients earlier in the multiple myeloma treatment paradigm to improve outcomes,” said Anne Kerber, MD, the Senior Vice President and Head of Late Clinical Development of Hematology, Oncology, Cell Therapy at Bristol Myers Squibb.
Data supporting the approval of ide-cel includes the pivotal, phase III KarMMa-3 study that compared ide-cel with conventional combination regimens in triple-class exposed adult patients who were refractory to their most recent therapy.
In KarMMa-3, ide-cel significantly improved progression-free survival (PFS) after a median follow-up of 30.9 months (range, 12.7-47.8) with a median PFS of 13.8 months versus 4.4 months with standard regimens (hazard ratio, 0.49; 95% CI, 0.38-0.63).
The recommendation for ide-cel will now be reviewed by the European Commission of the European Union, which typically makes a decision roughly two months after a CHMP opinion is submitted.
Related: Rafael Fonseca, MD, on CAR T-Cell Therapies in Earlier Myeloma Treatment Lines
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