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 akutna limfoblastna levkemija (ALL).
In ZUMA-3 (NCT02614066), a single-arm multicenter trial in individuals with relapsed or refractory B-cell precursor VSE, 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.
Popoln odziv (CR) v 3 mesecih po infuziji in trajnost CR sta bila merila za izid učinkovitosti, uporabljena v podporo odobritvi. V treh mesecih je 28 (52 odstotkov; 95-odstotni IZ: 38, 66) od 54 bolnikov, za katere je bilo mogoče oceniti učinkovitost, doseglo CR. Mediana trajanja CR ni bila dosežena z mediano spremljanja 7.1 meseca za odzivnike; pričakovano, da bo dolžina CR presegla 12 mesecev za več kot polovico bolnikov.
Opozorilo v okvirju za sindrom sproščanja citokinov (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 avtoleucel treatment, followed by fludarabine and cyclophosphamide for lymphodepleting chemotherapy.
