Avgust 2021: FDA bergan axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) ikki yoki undan ortiq bosqichli tizimli terapiyadan so'ng relapsli yoki refrakter follikulyar limfoma (FL) bo'lgan katta yoshli bemorlar uchun tezlashtirilgan tasdiqlash.
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.
Xolis ko'rib chiqish qo'mitasi samaradorlikning asosiy ko'rsatkichlarini aniqladi: ob'ektiv javob darajasi (ORR) va javob muddati (DOR). Birlamchi samaradorlik tahlilida 91 bemor orasida ORR 95 foizni (83 foiz CI: 96, 81) tashkil etdi, to'liq remissiya (CR) darajasi 60 foizni va o'rtacha javob vaqti bir oyni tashkil etdi. O'rtacha DORga erishilmadi va bemorlarning 76.2 foizi bir yildan keyin remissiyada qoldi (95 foiz CI: 63.9, 84.7). Ushbu sinovda barcha leykaferli bemorlar uchun ORR 89 foizni (95 foiz CI: 83, 94) tashkil etdi (n = 123), CR darajasi 62 foizni tashkil etdi.
A boxed warning for sitokinlarni chiqarish sindromi (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). Chr, 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.
