Bristol-Myers Squibb’s Immunotherapy ‘Abecma’, Gets Approval Of Japanese Health Ministry

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Bristol-Myers Squibb, on Thursday, announced that Japan’s Ministry of Health, Labour, and Welfare has approved the pharma firm’s Immunotherapy, Abecma, to treat multiple myeloma in adult patients. Multiple myeloma is an incurable disease, despite breakthroughs in treatment, and many patients experience periods of remission and relapse. Abecma (idecabtagene vicleucel) is 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.

There have been no approved therapy alternatives for multiple myeloma patients in Japan who have had three or more prior treatments, including an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody, until now. As a result, there is a huge unmet medical demand for new, effective treatments. Abecma is the first CAR T cell therapy approved for the treatment of R/R multiple myeloma in Japan. The approval is based on efficacy and safety data sourced from the global Studies conducted in two phases.

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 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 will get access to Abecma.

“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.”

Jean-Christophe Barland, President and CEO of Bristol-Myers Squibb K.K.

Dr. Tadao Ishida of the Japanese Red Cross Medical Center, who participated in the clinical study of Abecma, said, “I am delighted that Abecma has been approved as the first CAR T cell therapy in Japan targeting BCMA. We hope that this cell therapy will bring new hope to patients suffering from relapsed or refractory multiple myeloma. To make full use of this new CAR T cell therapy, the cooperation and collaboration of doctors and others who will be involved in its dispensation will be essential. It will also be important for doctors to work closely together with companies involved. We will work diligently to develop a robust treatment system incorporating the proper use of Abecma so that we can contribute to the treatment of as many patients with multiple myeloma as possible.”

The personalized immune cell therapy is approved as a one-time infusion. As an anti-BCMA CAR T cell therapy, 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.

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