August 2021: Iyo FDA yakapa axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) kukurumidza kubvumidzwa kwevakuru varwere vane vakadzokazve kana kusagadzikana follicular lymphoma (FL) mushure memaviri kana anopfuura mitsara ye systemic kurapa.
A single-arm, open-label, multicenter trial (ZUMA-5; NCT03105336) evaluated axicabtagene ciloleucel, a CD19-directed chimeric antigen receptor (CAR) T cell therapy, in adult patients with relapsed or refractory FL after two or more lines of systemic therapy, including the combination of an anti-CD20 monoclonal antibody and an alkylating agent, in adult patients with relapsed A single intravenous infusion of axicabtagene ciloleucel was given after lymphodepleting chemotherapy.
Dare rekuongorora risingasaruri rakatsanangura matanho makuru ekubudirira: chinangwa chekupindura (ORR) uye nguva yekupindura (DOR). Iyo ORR yaive 91 muzana (95 muzana CI: 83, 96) pakati pevarwere makumi masere nevanomwe mukuongorora kwekutanga kwekubudirira, iine kuregererwa kwakazara (CR) chiyero che81 muzana uye yepakati-mhinduro-yemwedzi mumwe. Iyo yepakati DOR haina kusvika, uye 60 muzana yevarwere vakaramba vari mukuregererwa mushure megore rimwe (76.2 muzana CI: 95, 63.9). Iyo ORR yaive 84.7 muzana (89 muzana CI: 95, 83) yevarwere vese vane leukapheresed muyedzo iyi (n = 94), ine CR mwero we123 muzana.
A boxed warning for cytokine release syndrome (CRS) and neurologic toxicities is included in the prescribing material for axicabtagene ciloleucel. CRS occurred in 88 percent (Grade 3, 10%) of patients with non-lymphoma Hodgkin’s (NHL) in investigations using axicabtagene ciloleucel, while neurologic toxicities occurred in 81 percent (Grade 3, 26 percent). CRS, fever, hypotension, encephalopathy, tachycardia, fatigue, headache, febrile neutropenia, nausea, infections with pathogen unspecified, decreased appetite, chills, diarrhoea, tremor, musculoskeletal pain, cough, hypoxia, constipation, vomiting, arrhythmias, and dizziness are the most common non-laboratory adverse reactions (incidence 20%) in patients with NHL.
