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 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.
The ALL Hub is an independent medical education platform, sponsored by Jazz Pharmaceuticals, Amgen, and Pfizer and supported through an educational grant from the Hippocrate Conference Institute, an association of the Servier Group. The funders are allowed no direct influence on our content. The levels of sponsorship listed are reflective of the amount of funding given. View funders.
Now you can support HCPs in making informed decisions for their patients
Your contribution helps us continuously deliver expertly curated content to HCPs worldwide. You will also have the opportunity to make a content suggestion for consideration and receive updates on the impact contributions are making to our content.
Find out more
Create an account and access these new features:
Bookmark content to read later
Select your specific areas of interest
View all content recommended for you
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.
References
Please indicate your level of agreement with the following statements:
The content was clear and easy to understand
The content addressed the learning objectives
The content was relevant to my practice
I will change my clinical practice as a result of this content
Your opinion matters
On average, how many patients with T-cell acute lymphoblastic leukemia do you see in a year?
