June 2022: Mushure memitsara miviri kana kupfuura yesystemic therapy, iyo FDA yakapa tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) yakakurumidza kubvumidzwa kuvarwere vakura vane kudzokazve kana refractory follicular lymphoma (FL).
Mvumo yacho yakabva pamigumisiro yekuedza kweELARA (NCT03568461), yakawanda, ruoko-rumwe chete, yakazaruka-label kuedza kuongorora tisagenlecleucel, CD19-directed chimeric antigen receptor (CAR) T cell therapy, muvarwere vakuru vakanga vachiramba kana yakadzokazve mukati memwedzi mitanhatu mushure mekupedza mitsetse miviri kana kupfuura ye systemic therapy (kusanganisira anti-CD6 antibody uye alkylating agent) kana Tisagenlecleucel yakapihwa senge intravenous infusion mushure me lymphodepleting chemotherapy, ine targeting ye20 kusvika 0.6 x 6.0 CAR- T masero akanaka anoshanda.
Iyo yakazara mhinduro mwero (ORR) uye nguva yekupindura (DOR), sezvakasimbiswa neyakazvimiririra yekuongorora komiti, ndiyo yaive huru yekubudirira matanho. IORR yaiva 86 muzana (95 muzana CI: 77, 92) pakati pevarwere ve90 muhutano hwekutanga hwekushanda, neCR chiyero che68 muzana (95 muzana CI: 57, 77). Iyo yepakati DOR haina kusangana, ne75% yevakapindura (95 muzana CI: 63, 84) vachiri kupindura mushure memwedzi ye9. IORR yaiva 86 muzana (95 muzana CI: 77, 92) yevarwere vose vane leukapheresis (n = 98), ine CR chiyero che67 muzana (95 muzana CI: 57, 76).
Cytokine kuburitsa chirwere, infection, weariness, musculoskeletal pain, headache, and diarrhoea were the most prevalent adverse effects in patients (>20 percent). 0.6 to 6.0 x 108 CAR-positive viable T cells is the suggested tisagenlecleucel dose.
