News
BMS receives approval for Abecma , the first CAR T therapy approved for the treatment of multiple myeloma in Japan.
Bristol-Myers Squibb K.K. announced that Japan’s Ministry of Health, Labour and Welfare has approved Abecma (idecabtagene vicleucel), a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy, for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma, who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody, and have either experienced disease progression on the last therapy or relapse after the last therapy.
Abecma is the first CAR T cell therapy approved for the treatment of R/R multiple myeloma in Japan. With this approval, Bristol Myers Squibb is now the only company in Japan with two approved CAR T cell therapies—the CD19-directed Breyanzi, which received approval in March 2021, and the BCMA-directed Abecma.
The approval is based on efficacy and safety data sourced from the global Phase II Study BB2121-MM-001 conducted in Japan, the U.S., the EU, and Canada, and the Phase 1 Study CRB-401 in the U.S.
Condition: Multiple Myeloma
Type: drug
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