2021 Agustus: FDA parantos masihan axicabtagene ciloleucel (Yescarta, Kite Pharma, Inc.) persetujuan expedited pikeun penderita sawawa kalawan lymphoma follicular kambuh atawa refractory (FL) sanggeus dua atawa leuwih garis terapi sistemik.
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.
Panitia tinjauan anu henteu bias ngartikeun ukuran-tingkat keberhasilan utama: tingkat réspon objektif (ORR) sareng durasi réspon (DOR). ORR mangrupikeun 91 persén (95 persén CI: 83, 96) diantara 81 pasién dina analisa efficacy primér, kalayan tingkat remisi (CR) lengkep 60 persén sareng median time-to-response hiji bulan. DOR median henteu ngahontal, sareng 76.2 persén pasién tetep di remisi saatos sataun (95 persén CI: 63.9, 84.7). ORR éta 89 persén (95 persén CI: 83, 94) pikeun sadaya pasién leukapheresed dina sidang ieu (n = 123), kalayan tingkat CR 62 persén.
A boxed warning for Sindrom pelepasan sitokin (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.
