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On January 22, 2024, the U.S. Food and Drug Administration (FDA) accepted a Biologics License Application for obecabtagene autoleucel (obe-cel), a novel autologous CD19 CAR T-cell therapy designed with a fast off-rate CD19 binding domain to improve persistence and reduce toxicities, for the treatment of adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia. This decision was based on data from the pivotal phase II FELIX study (NCT04404660).1,2
The ALL hub previously reported the efficacy and safety outcomes from the FELIX study. Updated data was presented at the 65th American Society of Hematology (ASH) Annual Meeting and Exposition. A total of 127 patients were infused with obe-cel. By the data cut-off on September 13, 2023,
For this indication, obe-cel previously received Orphan Drug Designation and Regenerative Medicine Advanced Therapy designation by the FDA, as well as Orphan Medical Product Designation and Priority Medicines designation by the European Medicines Agency (EMA).1
Real-world outcomes of brexu-cel in R/R adult ALL
Here, we summarize four key studies on the real-world outcomes of brexu-cel in relapsed/refractory adult acute lymphoblastic leukemia, presented at the 65th American Society of Hematology (ASH) Annual...
Efficacy and safety of obe-cel in R/R adult B-ALL: Phase II FELIX study
Here, we summarize the efficacy and safety results of the phase II FELIX study investigating obe-cel in adult patients with R/R B-ALL, presented by Claire Roddie at the 2023 ASCO...
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