Current status and issues with CAR-T cell products in Japan: a regulatory perspective
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M Nakamura, S Noda, A Nishikawa…
International Journal of …, 2026
Springer
The development of chimeric antigen receptor (CAR)-T cell products is accelerating worldwide. CAR-T cell therapy represents one of the most significant therapeutic advances, as it elicits remarkably effective and durable clinical responses. Approved CAR-T cell products target one of two antigens on B cells: CD19 or B cell maturation antigen (BCMA). In Japan, all CAR-T cell products are approved for the treatment of relapsed or refractory hematologic malignancies, including acute lymphoblastic leukemia, B cell lymphomas, and …
