Bristol Myers Squibb and 2seventy bio, Inc. received approval from the U.S. FDA for Abecma (idecabtagene vicleucel; ide-cel) for the treatment of adults with relapsed or refractory multiple myeloma after two or more prior lines of therapy including an immunomodulatory agent (IMiD), a proteasome inhibitor (PI), and an anti-CD38 monoclonal antibody, based on results from the KarMMa-3 trial. 
 
This approval expands Abecma’s indication, making it available in earlier lines to patients who have relapsed or become refractory after exposure to these three main classes of treatment (triple-class exposed), after two prior lines of therapy. Abecma is administered as a one-time infusion, with a new recommended dose range of 300 to 510 x 106 CAR-positive T cells. 
 
There are limited options for triple-class exposed relapsed and/or refractory multiple myeloma patients and associated with poor outcomes and a median progression-free survival (PFS) of three to five months. In this patient population with high unmet need, Abecma has demonstrated clinically meaningful and statistically significant improvements in PFS 13.3 months vs. 4.4 months. In addition, Abecma exhibited a well-established safety profile with mostly low-grade cytokine release syndrome and neurotoxicity. No cases of Parkinsonism were reported in the study.
 
To support this approval and future expansions, Bristol Myers Squibb has made continuous investments to increase manufacturing capacity and has shown a consistently high manufacturing success rate of 94% for Abecma in the commercial setting.
 
Abecma was recently approved in Japan, Switzerland and the EU for adult patients with triple-class exposed relapsed and/or refractory multiple myeloma after two prior lines of therapy, making it the only CAR T cell therapy available globally for earlier lines of therapy for patients with triple-class exposed relapsed and/or refractory multiple myeloma. Abecma is also currently approved in Great Britain and Israel for adults with triple-class exposed relapsed and refractory multiple myeloma after three or more prior lines of therapy.