Published on 8 Apr 2024 on Zacks via Yahoo Finance
Bristol Myers Squibb BMY announced that the FDA approved a label expansion for chimeric antigen receptor (CAR) T cell immunotherapy Abecma. The therapy is now approved for the treatment of adult patients 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.
It is to be noted that Abecma is being jointly developed and commercialized in the United States by Bristol Myers Squibb and 2seventy bio TSVT. Outside the United States, BMY assumes the sole responsibility for Abecma’s manufacturing and commercialization.
The latest approval, granted on Apr 4, was based on results from the KarMMa-3 trial, wherein Abecma tripled progression-free survival compared to standard regimens, with a 51% reduction in risk of disease progression or death and a well-established safety profile.