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. If you are a patient or carer, please visit Know ALL.

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

The ALL Hub website uses a third-party service provided by Google that dynamically translates web content. Translations are machine generated, so may not be an exact or complete translation, and the ALL Hub cannot guarantee the accuracy of translated content. The ALL Hub and its employees will not be liable for any direct, indirect, or consequential damages (even if foreseeable) resulting from use of the Google Translate feature. For further support with Google Translate, visit Google Translate Help.

Steering CommitteeAbout UsNewsletterContact

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

Sep 8, 2022
Learning objective: After reading this article, learners will be able to cite a new clinical development in 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.

  1. Business Wire. Kite’s CAR T-cell therapy Tecartus® granted European marketing authorization for the treatment of relapsed or refractory acute lymphoblastic leukemia (r/r ALL).