Bristol Myers Squibb announced a significant advancement in the treatment of multiple myeloma with the European Commission's approval of Abecma® (idecabtagene vicleucel, ide-cel) as the first CAR T cell therapy for earlier lines of therapy in relapsed and refractory multiple myeloma patients within the European Union. This approval is set to change the treatment landscape for patients who have already been treated with at least two prior therapies, including an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody, and who have shown disease progression on the last therapy.

The approval follows compelling results from the Phase 3 KarMMa-3 trial, where Abecma demonstrated a 51% reduction in the risk of disease progression or death compared to standard regimens. Additionally, the treatment has shown a well-established safety profile, characterized by mostly low-grade and transient occurrences of cytokine release syndrome and neurotoxicity.

This milestone underscores Bristol Myers Squibb’s dedication to pioneering cell therapy treatments and offering new hope to patients facing triple-class exposed relapsed and refractory multiple myeloma. The approval of Abecma in the EU not only provides a crucial new treatment option for patients but also marks a promising shift in the therapeutic approach to this challenging disease. With this expanded approval, Bristol Myers Squibb aims to bring this transformative treatment option to patients in need, supported by significant increases in manufacturing capacity to meet the anticipated demand.