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2024-11-11T16:18:03.000Z

FDA grants marketing approval for obecabtagene autoleucel for adult patients with R/R B-ALL

Nov 11, 2024
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Learning objective: After reading this article, learners will be able to cite a new clinical development in B-cell ALL.

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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 reportedon 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.  

  1. 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. 
  2. Business Wire. Autolus Therapeutics announces FDA approval of AUCATZYL® (obecabtagene autoleucelobe-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. 

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