Oktober 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 leukemia limfoblastik akut (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.
Réspon lengkep (CR) dina 3 bulan infus sareng daya tahan CR mangrupikeun kriteria hasil efficacy anu dianggo pikeun ngadukung persetujuan. Dina tilu bulan, 28 (52 persén; 95 persén CI: 38, 66) tina 54 pasien evaluable pikeun éféktivitas attained CR. Durasi median CR teu patepung jeung median nurutan-up of 7.1 bulan pikeun responders; panjang CR ieu diantisipasi ngaleuwihan 12 bulan pikeun leuwih ti satengah pasien.
A warning boxed pikeun Sindrom pelepasan sitokin (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.
