FDA Approves Brexucabtagene Autoleucel for the Treatment of Relapsed/Refractory ALL


The FDA has approved the use of CD19-directed CAR T-cell therapy brexucabtagene autoleucel for adult patients with relapsed/refractory precursor acute lymphoblastic leukemia.

Brexucabtagene autoleucel (Tecartus) was approved by the FDA for the treatment of adults with relapsed/refractory B-cell precursor acute lymphoblastic leukemia (ALL), according to the FDA.

The CD19-directed CAR T-cell therapy was evaluated as part of the phase 2 ZUMA-3 study (NCT02614066) in the indicated patient population. After receiving a single infusion, 52% (95% CI, 38%-66%)of the 52 patients evaluated achieved a complete response (CR) within 3 months. After a median follow up of 7.1 months, the median duration of CR was not reached, although it was estimated to have surpassed 12 months for half of patients.

Additionally, cytokine release syndrome (CRS) occurred in 92% of patients, including 26% who experienced grade 3 or higher CRS. Additionally, 87% of patients experienced neurologic toxicities, including 35% who experienced an adverse effect (AE) of grade 3 or higher. Other AEs included fever, hypotension, encephalopathy, tachycardias, nausea, chills, headache, and fatigue.


FDA approves brexucabtagene autoleucel for relapsed or refractory B-cell precursor acute lymphoblastic leukemia. News release. October 1, 2021. Accessed October 4, 2021. https://bit.ly/3irFWFV

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Gregory W. Roloff, MD, indicates that brexucabtagene autoleucel did not yield significant positive findings in patients with relapsed/refractory B-cell acute lymphoblastic leukemia who were MRD positive.
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