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Japanese approval of axicabtagene ciloleucel for the treatment of R/R large B-cell lymphomas
On January 22, 2021, it was announced that the Japanese Ministry of Health, Labour and Welfare approved the use of axicabtagene ciloleucel, a CD19 chimeric antigen receptor T-cell therapy, for the treatment of relapsed/refractory (R/R) large B-cell lymphomas, including primary mediastinal B-cell lymphoma, transformed follicular lymphoma, and high-grade B-cell lymphoma. This approval was based on the results from the pivotal ZUMA-1 study, previously reported on the Lymphoma Hub, and data from a phase II trial, specifically looking at efficacy and safety in Japanese patients (n = 16).1
The Japanese trial showed an objective response rate of 86.7% (95% CI, 59.5–98.3) and a similar overall safety and tolerability profile as that reported for ZUMA-1. Axicabtagene ciloleucel is also approved by the U.S Food and Drug Administration (FDA) and European Medicines Agency (EMA) for patients with R/R B-cell lymphomas.1
References
- Daiichi-Sankyo. YESCARTA® approved in Japan for treatment of patients with relapsed/refractory large B-cell lymphomas. https://www.daiichisankyo.com/media/press_release/detail/index_4117.html. Published Jan 22, 2021. Accessed Jan 26, 2021.
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This content is accurate as of the date of publication and is not updated retrospectively. Please refer to the latest available evidence, guidelines, and relevant regulatory information when making clinical decisions.
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