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