August 2021: FDA ayaa bixisay axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) Oggolaanshaha degdega ah ee bukaanada qaangaarka ah ee soo noqnoqda ama follicular limfoma (FL) ka dib laba ama in ka badan oo daawaynta habdhiska ah.
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.
Gudida dib u eegista eexasho la'aanta ayaa qeexday tallaabooyinka waxtarka leh: heerka jawaabta ujeeddada (ORR) iyo muddada jawaabta (DOR). ORR wuxuu ahaa 91 boqolkiiba (95 boqolkiiba CI: 83, 96) oo ka mid ah bukaannada 81 ee falanqaynta waxtarka aasaasiga ah, oo leh heerka cafis dhammaystiran (CR) ee boqolkiiba 60 iyo dhexdhexaadinta waqtiga-jawaab-celinta hal bil ah. Dhexdhexaadka DOR lama gaarin, iyo 76.2 boqolkiiba bukaanada ayaa ku haray cafiska hal sano kadib (95 boqolkiiba CI: 63.9, 84.7). ORR wuxuu ahaa 89 boqolkiiba (95 boqolkiiba CI: 83, 94) dhammaan bukaannada leukaphered ee tijaabadan (n=123), oo leh heerka CR ee 62 boqolkiiba.
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.
