Oktoba 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 m lymphoblastic cutar sankarar bargo (ALL).
In ZUMA-3 (NCT02614066), a single-arm multicenter trial in individuals with relapsed or refractory B-cell precursor ALL, 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.
Cikakken amsa (CR) a cikin watanni 3 na jiko da dorewa na CR sune ingantattun ka'idojin sakamakon da aka yi amfani da su don tallafawa yarda. A cikin watanni uku, 28 (kashi 52; 95 bisa dari CI: 38, 66) na marasa lafiya 54 da aka kimanta don tasiri sun sami CR. Tsawon lokacin tsaka-tsaki na CR ba a sadu da shi tare da biyan kuɗi na watanni 7.1 don masu amsawa; Ana tsammanin tsawon CR ya wuce watanni 12 fiye da rabin marasa lafiya.
A boxed gargadi ga Ciwon saki na cytokine (CRS) 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.
