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
Introducing
Now you can personalise
your ALL Hub experience!
Bookmark content to read later
Select your specific areas of interest
View content recommended for you
Find out moreThe 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.
The ALL Hub is an independent medical education platform, sponsored by Jazz Pharmaceuticals, Amgen, and Pfizer. 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.
FDA grants marketing approval for obecabtagene autoleucel for adult patients with R/R B-ALL
Bookmark this article
On November 8, 2024, it was announced that the U.S. Food and Drug Administration (FDA) had granted marketing approval for obecabtagene autoleucel (obe-cel), a CD19-directed genetically modified autologous CAR T-cell therapy, for the treatment of adult patients with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (B-ALL). 1,2 This approval is based on the promising outcomes from the phase Ib/II FELIX study (NCT04404660).1,2
FELIX study1,2
FELIX is an ongoing phase Ib/II, open-label, multicenter, single-arm study designed to evaluate the safety and efficacy of obe-cel in adult patients with B-ALL. The ALL Hub previously reported on the efficacy and safety and tumor burden-guided dosing data for obe-cel from the FELIX study.
The key results were as follows:
-
Among the efficacy-evaluable patients (n = 65), 63% achieved overall complete remission (CR), comprising 51% with CR at any time and 12% with CR with incomplete hematologic recovery at any time.
-
The primary efficacy outcome, CR within 3 months, was reached by 42% of patients, with a median remission duration of 14.1 months.
-
Obe-cel demonstrated low rates of cytokine release syndrome, with only 3% experiencing Grade 3 events, and no Grade 4 or 5 events. Grade ≥3 immune effector cell-associated neurotoxicity syndrome occurred in 7% of patients.
-
The FDA did not require a risk evaluation mitigation strategy for obe-cel.
This approval addresses a significant unmet medical need, as adult ALL is an aggressive cancer with poor outcomes upon relapse.
- U.S. Food & Drug Administration. FDA approves obecabtagene autoleucel for adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia. https://www.fda.gov/drugs/resources-information-approved-drugs/fda-approves-obecabtagene-autoleucel-adults-relapsed-or-refractory-b-cell-precursor-acute?utm_medium=email&utm_source=govdelivery. Published Nov 8, 2024. Accessed Nov 11, 2024.
- Business Wire. Autolus Therapeutics announces FDA approval of AUCATZYL® (obecabtagene autoleucel – obe-cel) for adults with relapsed/refractory B-cell acute lymphoblastic leukemia (r/r B-ALL) https://www.globenewswire.com/en/news-release/2024/11/08/2977884/0/en/Autolus-Therapeutics-Announces-FDA-Approval-of-AUCATZYL-obecabtagene-autoleucel-obe-cel-for-adults-with-relapsed-refractory-B-cell-acute-lymphoblastic-leukemia-r-r-B-ALL.html. Published Nov 8, 2024. Accessed Nov 11, 2024.
Your opinion matters
6 votes - 50 days left ...
Related articles
Newsletter
Subscribe to get the best content related to ALL delivered to your inbox