Abecma is a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy. It recognizes and binds to BCMA, a protein that is nearly universally expressed on cancer cells in multiple myeloma, leading to the death of BCMA-expressing cells.
The CAR-T therapy is already approved in Europe, as well as in the US, where the treatment is available for myeloma patients who have received at least four prior therapies.
In the US, Abecma is being jointly developed and commercialized by Bristol Meyers Squibb (BMS) and Bluebird Bio, while BMS holds exclusive manufacturing and commercialization rights outside the US.
The approval of Abecma in Japan is based on efficacy and safety data sourced from the global Phase 2 Study, BB2121-MM-001, conducted in Japan, the US, the EU, and Canada, and the Phase 1 Study, CRB-401, undertaken in the US
The target group for the CAR T-cell therapy there would be patients treated at least with one immunomodulatory drug (IMiD), one proteasome inhibitor (PI), and one CD38 inhibitor, and whose disease failed to respond or relapsed after their last therapy.
No other treatment is approved for this group of patients in Japan. Consequently, there is a significant unmet medical need for novel, effective therapies, said BMS in a release.
BMS is now the only company in Japan with two approved CAR T cell therapies following this approval and the greenlight given to the pharma giant’s CD19-directed Breyanzi in March 2021.