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On October 1, 2021, the U.
S.
Food and Drug Administration (FDA) approved brexucabtagene autoleucel for the treatment of adult patients with relapsed and refractory precursor B-cell acute lymphoblastic leukemia (ALL)
.
The ZUMA-3 study (NCT02614066) is a single-arm, multicenter trial that evaluated the efficacy of brexucabtagene autoleucel, a chimeric antigen receptor (CAR) T cell targeting CD19, in adult patients with relapsed and refractory precursor B-cell ALL
.
The patient received a single infusion of brexucabtagene autoleucel after completing the lymphocyte depletion chemotherapy
.
The efficacy outcome indicators used to support this approval are complete remission (CR) and CR duration within 3 months after infusion
.
Among 54 patients with evaluable efficacy, 28 patients (52%; 95% CI: 38, 66) achieved CR within 3 months
.
The median follow-up time of patients in remission was 7.
1 months, and the median CR duration was not reached; it is estimated that more than half of the patients had CR duration of more than 12 months
.
The prescribing information for brexucabtagene autoleucel contains black box warnings about cytokine release syndrome (CRS) and neurotoxicity
.
92% (≥Grade 3, 26%) of patients developed CRS, and 87% (≥Grade 3, 35%) of patients developed neurological toxicity
.
The most common non-laboratory adverse reactions (incidence ≥20%) include fever, CRS, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain , Hypoxia, skin rash, edema, tremor, infection with unknown pathogens, constipation, loss of appetite and vomiting
.
The recommended dose of brexucabtagene autoleucel is a single intravenous infusion of 1x106 CAR-T cells per kilogram of body weight (up to 1x108 CAR-T cells)
.
Reference source: https:// Stamp" to read Original ", we make progress together
S.
Food and Drug Administration (FDA) approved brexucabtagene autoleucel for the treatment of adult patients with relapsed and refractory precursor B-cell acute lymphoblastic leukemia (ALL)
.
The ZUMA-3 study (NCT02614066) is a single-arm, multicenter trial that evaluated the efficacy of brexucabtagene autoleucel, a chimeric antigen receptor (CAR) T cell targeting CD19, in adult patients with relapsed and refractory precursor B-cell ALL
.
The patient received a single infusion of brexucabtagene autoleucel after completing the lymphocyte depletion chemotherapy
.
The efficacy outcome indicators used to support this approval are complete remission (CR) and CR duration within 3 months after infusion
.
Among 54 patients with evaluable efficacy, 28 patients (52%; 95% CI: 38, 66) achieved CR within 3 months
.
The median follow-up time of patients in remission was 7.
1 months, and the median CR duration was not reached; it is estimated that more than half of the patients had CR duration of more than 12 months
.
The prescribing information for brexucabtagene autoleucel contains black box warnings about cytokine release syndrome (CRS) and neurotoxicity
.
92% (≥Grade 3, 26%) of patients developed CRS, and 87% (≥Grade 3, 35%) of patients developed neurological toxicity
.
The most common non-laboratory adverse reactions (incidence ≥20%) include fever, CRS, hypotension, encephalopathy, tachycardia, nausea, chills, headache, fatigue, febrile neutropenia, diarrhea, musculoskeletal pain , Hypoxia, skin rash, edema, tremor, infection with unknown pathogens, constipation, loss of appetite and vomiting
.
The recommended dose of brexucabtagene autoleucel is a single intravenous infusion of 1x106 CAR-T cells per kilogram of body weight (up to 1x108 CAR-T cells)
.
Reference source: https:// Stamp" to read Original ", we make progress together
