Juni 2022: Ngemva kwemigqa emibili noma ngaphezulu yokwelashwa kwe-systemic, i-FDA yaklomelisa i-tisagenlecleucel (Kymriah, Novartis Pharmaceuticals Corporation) yagunyaza ngokushesha iziguli ezikhulile ezine-lymphoma ye-follicular (FL) ebuyele emuva noma ye-refractory.
Ukugunyazwa kwakusekelwe emiphumeleni yokuhlolwa kwe-ELARA (NCT03568461), ukuhlolwa kwe-multicenter, ingalo eyodwa, ilebula evulekile ehlola i-tisagenlecleucel, i-CD19-directed chimeric antigen receptor (CAR) T cell therapy, ezigulini ezikhulile ezaziphikisana noma iphinde yabuyela emuva phakathi nezinyanga ezingu-6 ngemva kokuqeda imigqa emibili noma ngaphezulu yokwelapha okuhleliwe (okuhlanganisa i-anti-CD20 antibody kanye ne-alkylating ejenti) noma i-Tisagenlecleucel yanikezwa njengokufakwa emthanjeni okukodwa ngemva kwe-lymphodepleting chemotherapy, onomthamo ohlosiwe ongu-0.6 kuya ku-6.0 x 108 CAR- ama-T cell asebenzayo.
Izinga lokuphendula eliphelele (i-ORR) kanye nobude besikhathi sokuphendula (DOR), njengoba kusungulwe ikomidi elibuyekezayo elizimele, kwakuyizinyathelo ezinkulu zokusebenza ngempumelelo. I-ORR yayingamaphesenti angu-86 (amaphesenti angu-95 CI: 77, 92) phakathi kweziguli ezingu-90 ekuhlaziyweni kokusebenza kahle okuyinhloko, ngesilinganiso se-CR samaphesenti angu-68 (amaphesenti angu-95 CI: 57, 77). I-DOR emaphakathi ayizange ihlangabezane, nama-75% abaphenduli (amaphesenti angu-95 CI: 63, 84) asaphendula ngemva kwezinyanga ezingu-9. I-ORR yayingamaphesenti angu-86 (amaphesenti angu-95 CI: 77, 92) kuzo zonke iziguli ezine-leukapheresis (n = 98), nesilinganiso se-CR samaphesenti angu-67 (amaphesenti angu-95 CI: 57, 76).
I-Cytokine release syndrome, 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.
