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Brexucabtagene autoleucel approved by the FDA for use in adult ALL

Oct 5, 2021

On October 1, 2021, brexucabtagene autoleucel (brexu-cel) became the first chimeric antigen receptor (CAR) T-cell therapy to be approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with acute lymphoblastic leukemia (ALL). Brexu-cel is now indicated for patients aged ≥18 years with relapsed or refractory B-cell precursor ALL.

A supplemental biologics license application was submitted for the CD19-directed CAR T-cell therapy in April 2021 based on the encouraging responses observed in the ZUMA-3 trial (NCT02614066). The ongoing phase I/II study is evaluating the safety and efficacy of brexu-cel in adult patients with relapsed or refractory ALL following standard systemic therapy or hematopoietic stem cell transplantation. At a median follow-up of 12.3 months, complete remission (CR)/CR with incomplete hematologic recovery (CRi) was observed in 65% of evaluable patients (n = 54). The median duration of CR was expected to surpass 12 months in over half of patients. Median duration of remission was 13.6 months across efficacy-evaluable patients, and cytokine release syndrome and neurologic events were controlled in patients who received the target dose (n = 78). The pivotal phase II results of the ZUMA-3 trial were recently published in Lancet.

Relapse rates in adult ALL are high and overall survival remains suboptimal; the approval of brexu-cel may go some way to address the unmet need in this patient population. Brexu-cel is also being evaluated for the treatment of pediatric patients with ALL.

  1. BusinessWire. U.S. FDA approves Kite’s Tecartus® as the first and only Car T for adults with relapsed or refractory B-cell acute lymphoblastic leukemia. Published Oct 1, 2021. Accessed Oct 4, 2021.