Bristol-Myers Squibb’s Abecma Becomes First Approved CAR T-Cell Therapy for Multiple Myeloma in Japan

Bristol-Myers Squibb K.K has received approval from Japan’s Ministry of Health, Labour and Welfare for Abecma (idecabtagene vicleucel), its chimeric antigen receptor (CAR) T cell immunotherapy directed by a B-cell maturation antigen (BCMA), for the treatment of adult patients with relapsed or refractory (R/R) multiple myeloma.  Abecma is meant for patients 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.

Multiple Myeloma and the Unmet Need for Therapy. 

Multiple myeloma (MM) accounts for ~10% of all hematologic malignancies in the United States, with the highest incidences being observed in developed countries. Despite advances in treatment, multiple myeloma remains an incurable disease, and many patients suffer through periods of remission and relapse. B-cell maturation antigen (BCMA) has emerged as a promising target for MM therapies.

Until now there have been no approved therapeutic options in Japan for the treatment of multiple myeloma patients who have received three or more prior therapies, including an immunomodulatory agent, a proteasome inhibitor and an anti-CD38 antibody. Consequently, there is a significant unmet medical need for novel, effective therapies.

Efficacy of Abecma in Relapsed or Refractory (R/R) Multiple Myeloma

Abecma is the first CAR (chimeric antigen receptor ) T cell therapy approved for the treatment of R/R multiple myeloma in Japan. It is administered as a one-time infusion, and identifies and attaches to the BCMA protein as an anti-BCMA CAR T cell therapy. BCMA (B-cell maturation antigen ) is universally expressed on multiple myeloma cancer cells and results in their death.

The approval for Abecma is based on efficacy and safety data sourced from the global Phase 2 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.With the approval of Abecma, 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.

Jean-Christophe Barland, President and CEO of Bristol-Myers Squibb K.K., said, “I am very pleased that we have received approval for our second CAR T cell therapy, thus becoming the first and only company in Japan to receive approval for two CAR T cell therapies with distinct targets across multiple diseases. Abecma delivers a new treatment option for patients with multiple myeloma, the first option directed against BCMA and using a new mode of action. This approval is a testament to our strong commitment to addressing unmet medical needs for patients in Japan. As a game-changer committed to ‘innovation with heart,’ Bristol Myers Squibb Japan will continue its efforts to help patients prevail over serious diseases.”

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Author

Arvind C. Shekhar