First CAR T-Cell Therapy for Multiple Myeloma Cleared for Use in Japan

According to a press release from the pharmaceutical company Bristol Myers Squibb, the company’s CAR T-Cell therapy idecabtagene vicleucel (marketed as Abecma) has been approved by the Japanese Ministry of Health, Labor, and Welfare for use in the country. Abecma is approved for the treatment of the rare blood cancer multiple myeloma in patients that have received three previous therapies including an immunotherapy treatment, an anti-CD38 antibody, and a proteasome inhibitor. Additionally, the patient must have experienced relapse or disease progression after the last treatment.

About Multiple Myeloma

Multiple myeloma, which is occasionally referred to as plasma cell myeloma, is a blood cancer that affects plasma cells. These are white blood cells that produce antibodies. The overall cause of multiple myeloma is not well understood, however, some risk factors have been identified. These include obesity, family history, smoldering myeloma, and monoclonal gammopathy of undetermined significance. These last two conditions have the potential to develop into multiple myeloma. Symptoms of this cancer include bone pain, infections, anemia, kidney failure, overly thick blood, confusion, fatigue, headaches, and amyloidosis. Treatment includes chemo, stem cell transplant, and other medications for relapsed disease, which is common. Five year survival rate is 49 percent in the US. To learn more about multiple myeloma, click here.

Abecma in Japan

Abecma will make history as the first CAR T-cell therapy approved for the treatment of multiple myeloma in the island nation. However, this is the second CAR T-cell therapy from the company that has been approved there (the other is for a different cancer). This approval is based on findings from the phase II global clinical trial which took place in the EU, Canada, the US, and Japan. In this trial, Japanese participants saw an overall response rate of 88.9 percent. Adverse effects, as with most CAR T-cell therapies, were common and included cytokine release syndrome (84.7%), neutropenia (59.9%), and thrombocytopenia (45.3%). This relatively high rate of adverse side effects is the primary reason why Abecma and most CAR T-cell therapies are not first line treatments.

Abecma is a B-cell maturation antigen (BCMA) directed form of the therapy. It recognizes and binds to BCMA and destroys cells that express it. Nearly all cancer cells in multiple myeloma express BCMA. The therapy is administered as a one time infusion.

With the approval of this therapy, Japanese patients with advanced relapsed or refractory multiple myeloma will have access to a new treatment that has the potential to improve their survival.

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