Agusta 2021: FDA ta bayar axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) hanzarta yarda ga marasa lafiya marasa lafiya tare da koma baya ko raunin ƙwayar lymphoma follicular (FL) bayan layuka biyu ko fiye na tsarin tsarin.
Hannun hannu guda ɗaya, alamar buɗewa, gwajin multicenter (ZUMA-5; NCT03105336) kimanta axicabtagene ciloleucel, CD19-directed chimeric antigen receptor (CAR) T cell far, a cikin manya marasa lafiya tare da koma baya ko refractory FL bayan biyu ko fiye layi na tsarin jiyya, gami da haɗin anti-CD20 monoclonal antibody da wakili na alkylating, a cikin manya marasa lafiya tare da sake dawowa An ba da jiko guda ɗaya na axicabtagene ciloleucel bayan ƙwayoyin cuta na lymphodepleting.
Wani kwamiti na bita da wariya ya bayyana manyan matakan inganci: ƙimar amsa haƙiƙa (ORR) da tsawon amsa (DOR). ORR ya kasance kashi 91 (95 bisa dari CI: 83, 96) a tsakanin marasa lafiya 81 a cikin binciken inganci na farko, tare da cikakkiyar gafara (CR) na kashi 60 cikin ɗari da tsaka-tsakin lokaci-zuwa-amsa na wata ɗaya. Ba a kai DOR na tsakiya ba, kuma kashi 76.2 na marasa lafiya sun kasance cikin gafara bayan shekara guda (95 bisa dari CI: 63.9, 84.7). ORR ya kasance kashi 89 (95 bisa dari CI: 83, 94) ga duk marasa lafiya na leukapheresed a cikin wannan gwajin (n = 123), tare da ƙimar CR na kashi 62.
A boxed warning for Ciwon saki na cytokine (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.
