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FDA grants marketing approval for obecabtagene autoleucel for adult patients with R/R B-ALL
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:
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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.
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The primary efficacy outcome, CR within 3 months, was reached by 42% of patients, with a median remission duration of 14.1 months.
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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.
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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.
References
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