Japanese approval of lisocabtagene maraleucel for the treatment of R/R LBCL

On March 25, 2021, it was announced that the Japanese Ministry of Health, Labour, and Welfare approved the use of lisocabtagene maraleucel, a CD19 chimeric antigen receptor T-cell therapy, for the treatment of relapsed/refractory (R/R) large B-cell lymphomas (LBCL) and R/R follicular lymphoma. This approval was based on the results of the phase I TRANSCEND NHL 001 study (NCT02631044), previously reported on the Lymphoma Hub and published in The Lancet. This approval was also based on the phase II TRANSCEND WORLD trial (2017-000106-38) results from the data cutoff on June 19, 2020.

The TRANSCEND WORLD trial results demonstrated an overall response rate of 63% for the 46 patients with aggressive B-cell lymphoma in the study population, and 70% in the ten Japanese patients. Adverse reactions occurred in 42/46 patients (including the ten Japanese patients) and consisted of neutropenia (52.2%), cytokine release syndrome (41.3%), anemia (39.1%), thrombocytopenia (39.1%), pyrexia (39.1%), leukopenia (23.9%), confusion (15.2%), fatigue (13.0%), and febrile neutropenia (13.0%).

Lisocabtagene maraleucel has already been approved by the U.S. Food and Drug Administration (FDA) for the treatment of adults with R/R LBCL after ≥ 2 lines of therapy.