Brexucabtagene autoleucel receives a positive opinion from EMA CHMP for the treatment of patients with R/R B-ALL

On July 22, 2022, it was announced that brexucabtagene autoleucel (brexu-cel) received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human use (CHMP) for the treatment of patients aged ≥26 years with relapsed/refractory (R/R) B-cell acute lymphoblastic leukemia (B-ALL). The decision was based on results from an extended follow-up analysis of the ZUMA-3 trial (NCT02614066).¹

The results, recently reported in the ALL Hub, demonstrated the durable efficacy and manageable safety profile of brexu-cel in adult patients with R/R B-ALL, with 71% achieving complete remission or complete remission with incomplete hematological recovery. The median overall survival was 25.4 months and no new safety signals were reported.  These findings were consistent with the primary analysis.

Given the high treatment burden and low-survival rate of patients with R/R B-ALL, approval of brexu-cel marks a positive treatment advancement, and the first chimeric antigen receptor T-cell therapy approved, for this population of patients.