All content on this site is intended for healthcare professionals only. By acknowledging this message and accessing the information on this website you are confirming that you are a Healthcare Professional.

The ALL Hub uses cookies on this website. They help us give you the best online experience. By continuing to use our website without changing your cookie settings, you agree to our use of cookies in accordance with our updated Cookie Policy

Brexucabtagene autoleucel approved by the FDA for use in adult ALL

Oct 5, 2021
Share:

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. https://www.businesswire.com/news/home/20211001005719/en/U.S.-FDA-Approves-Kite%E2%80%99s-Tecartus%C2%AE-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.

Share: