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FDA Approves Brexucabtagene Autoleucel CAR-T Therapy for R/R B-ALL
On October 1, 2021, the FDA approved brexucabtagene autoleucel (Tecartus, Kite Pharma Inc.) for the use in the treatment of adult patients with relapsed or refractory (R/R) B-cell precursor acute lymphoblastic leukemia (B-ALL).
This approval was based on efficacy outcomes from the single-arm, multicenter phase 1/2 ZUMA-3 study, which evaluated brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell therapy, in adults with R/R B-cell precursor ALL. The efficacy outcomes were complete response (CR) achieved within 3 months from infusion, and duration of CR.
Patients (n=54) received a single infusion of brexucabtagene autoleucel following the completion of lymphodepleting chemotherapy. Study findings showed that 28 patients (52%, 95% CI, 38-66) achieved CR within 3 months. With a median follow-up of 7.1 months, the median duration of CR was not reached. The duration of CR was estimated to exceed 12 months for more than half of the patients.
The FDA said the prescribing information for brexucabtagene autoleucel has a boxed warning for cytokine release syndrome (CRS) and neurological toxicities, due to CRS occurring in 92% (Grade ≥3, 26%) of patients and neurological toxicities occuring in 87% (Grade ≥3, 35%).
The most common (≥20%) non-laboratory adverse reactions included fever, CRS, hypotension, encephalopathy, tachycardias, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain, hypoxia, rash, edema, tremor, infection with pathogen unspecified, constipation, decreased appetite, and vomiting.
The FDA said it recommends the dosage of brexucabtagene autoleucel to be a single intravenous infusion of 1 x 106 CAR-positive viable T cells per kg body weight, preceded by fludarabine and cyclophosphamide for lymphodepleting chemotherapy.—Emily Bader
