Okthoba 2021: Brexucabtagene autoleucel (Tecartus, Kite Pharma, Inc.) kuvunywe i-Food and Drug Administration ezigulini ezikhulile ezine-B-cell precursor ebuyele emuva noma ephikisayo I-acute lymphoblastic leukemia (YONKE).
Ku-ZUMA-3 (NCT02614066), isilingo se-single-arm multicenter kubantu abane-B-cell precursor ebuyele emuva noma ephikisayo. KONKE, ukusebenza kahle kwe-brexucabtagene autoleucel, i-CD19-directed chimeric antigen receptor (CAR) Ukwelashwa kwe-T-cell, yahlolwa. Ngemva kwe-lymphodepleting chemotherapy, iziguli zithole ukumnika okukodwa kwe-brexucabtagene autoleucel.
Impendulo ephelele (i-CR) phakathi nezinyanga ezi-3 zokufakwa kanye nokuqina kwe-CR kwakuyimibandela yomphumela wokusebenza esetshenziselwa ukusekela ukugunyazwa. Ezinyangeni ezintathu, ama-28 (amaphesenti angama-52; amaphesenti angama-95 e-CI: 38, 66) ezigulini ezingama-54 ezingahlolwa ngokusebenza ngempumelelo athole i-CR. Isikhathi esimaphakathi se-CR asizange sihlangane nokulandelwa okumaphakathi kwezinyanga ze-7.1 zabaphenduli; ubude be-CR bekulindeleke ukuthi budlule izinyanga eziyi-12 ngaphezu kwesigamu seziguli.
Isexwayiso esisebhokisini se i-cytokine release syndrome (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 I-brexucabtagene autoleucel treatment, followed by fludarabine and cyclophosphamide for lymphodepleting chemotherapy.
