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 SEMUA, 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.
Respons lengkap (CR) dalam waktu 3 bulan infus dan daya tahan CR adalah kriteria hasil efikasi yang digunakan untuk mendukung persetujuan. Dalam waktu tiga bulan, 28 (52 persen; 95 persen CI: 38, 66) dari 54 pasien yang dievaluasi efektivitasnya mencapai CR. Durasi rata-rata CR tidak terpenuhi dengan median tindak lanjut 7.1 bulan untuk responden; panjang CR diantisipasi untuk melampaui 12 bulan untuk lebih dari setengah pasien.
Peringatan kotak untuk 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.
