Outubro de 2021: Brexucabtagene autoleucel (Tecartus, Kite Pharma, Inc.) has been approved by the Food and Drug Administration for adult patients with relapsed or refractory B-cell precursor leucemia linfoblástica aguda (LLA).
In ZUMA-3 (NCT02614066), a single-arm multicenter trial in individuals with relapsed or refractory B-cell precursor TODAS, the efficacy of brexucabtagene autoleucel, a CD19-directed chimeric antigen receptor (CAR) T-cell treatment, was assessed. Following lymphodepleting chemotherapy, patients received a single infusion of brexucabtagene autoleucel.
Resposta completa (CR) dentro de 3 meses da infusão e durabilidade de CR foram os critérios de resultado de eficácia utilizados para apoiar a aprovação. Em três meses, 28 (52 por cento; IC de 95 por cento: 38, 66) dos 54 pacientes avaliáveis quanto à eficácia alcançaram a RC. A duração mediana de CR não foi atendida com um acompanhamento mediano de 7.1 meses para respondedores; a duração da RC era esperada para ultrapassar 12 meses para mais da metade dos pacientes.
Um aviso em caixa para síndrome de liberação de citocinas (SRC) and neurologic toxicities is included in the prescribing material for brexucabtagene autoleucel. In 92 percent of cases (Grade 3, 26 percent), CRS developed, and in 87 percent of cases (Grade 3, 35 percent), neurologic toxicities occurred. Fever, CRS, hypotension, encephalopathy, tachycardias, nausea, chills, headache, fatigue, febrile neutropenia, diarrhoea, musculoskeletal pain, hypoxia, rash, edoema, tremor, infection with an unspecified pathogen, constipation, decreased appetite, and vomiting were the most common non-laboratory adverse reactions (incidence 20%).
A single intravenous infusion of 1 x 106 CAR-positive viable T cells per kg body weight (maximum 1 x 108 CAR-positive viable T cells) is advised for brexucabtagene autoleucel treatment, followed by fludarabine and cyclophosphamide for lymphodepleting chemotherapy.
