European Commission grants European marketing authorization to brexucabtagene autoleucel for the treatment of patients with R/R B-ALL

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).

• Brexu-cel showed durable efficacy and a manageable safety profile in adult patients with R/R B-ALL.
• With a median follow-up of 26.8 months, 71% of evaluable patients achieved complete remission or complete remission with incomplete hematologic recovery.
• In an extended dataset of all pivotal dosed patients (n = 78), the median overall survival was >2 years and almost 4 years for responders (patients who achieved complete remission or complete remission with incomplete hematologic recovery).
• The median duration of remission was 18.6 months for efficacy-evaluable patients.
• No new safety signals were reported.

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.