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On September 6, 2022, it was announced that brexucabtagene autoleucel (brexu-cel) received European marketing authorization from the European Commission for the treatment of patients aged ≥26 years with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL).1
The approval is based on results from the ZUMA-3 phase I/II trial (NCT02614066).
Given the high relapse rate, low survival rate, and high treatment burden in adult patients with B-ALL, this meaningful clinical development will be beneficial in addressing an unmet need in this population.
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