The FDA ( Food and Drug Administration ) has approved Tecartus ( Brexucabtagene autoleucel ) for adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia ( ALL ).
Efficacy was evaluated in ZUMA-3, a single-arm multicenter trial that has evaluated Brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor ( CAR ) T-cell therapy, in adults with relapsed or refractory B-cell precursor acute lymphoblastic leukemia.
Patients have received a single infusion of Brexucabtagene autoleucel following completion of lymphodepleting chemotherapy.
The efficacy outcome measures used to support approval were complete response ( CR ) achieved within 3 months from infusion and duration of CR.
Of the 54 patients evaluable for efficacy, 28 ( 52%; 95% CI: 38, 66 ) achieved complete response within 3 months.
With a median follow-up for responders of 7.1 months, the median duration of complete response was not reached; the duration of complete response was estimated to exceed 12 months for more than half the patients.
The prescribing information for Brexucabtagene autoleucel has a boxed warning for cytokine release syndrome ( CRS ) and neurologic toxicities.
Cytokine release syndrome occurred in 92% ( Grade 3 or more, 26% ) and neurologic toxicities occurred in 87% ( Grade 3 o more, 35% ).
The most common non-laboratory adverse reactions ( incidence 20% or more ) included fever, cytokine release syndrome, 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 recommended Brexucabtagene autoleucel dose is a single intravenous infusion of 1 x 10(6) CAR-positive viable T cells per kg body weight ( maximum 1 x 10(8) CAR-positive viable T cells ), preceded by Fludarabine and Cyclophosphamide for lymphodepleting chemotherapy. ( Xagena )
Source: FDA, 2021