August 2021: FDA dedit axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) expeditum approbationem pro aegris adultis lymphoma follicularis relapso vel refractorio (FL) post duas vel plures lineas therapiae systemicae.
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.
Intimum recensio committens maiorem efficaciam mensuras definivit: responsio obiectiva rate (ORR) et durationem responsionis (DOR). ORR 91 centesimas (95 cento CI: 83, 96) inter 81 aegros in analysi efficacia primario, cum remissione plenaria (CR) facta est 60 centesimis et medianis temporis ad responsionem unius mensis. Mediana DOR non pervenit, et 76.2 centesimas aegrorum in remissione post unum annum mansit (95 percent CI: 63.9, 84.7). ORR erat 89 percent (95 cento CI: 83, 94) omnibus aegris leukaphericis in hoc iudicio (n=123), cum rata CR 62 centesimis.
A boxed warning for cytokine syndrome release (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). CKS, 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.
