Septhemba 2022: I-Ibrutinib (Imbruvica, Pharmacyclics LLC) yagunyazwa i-Food and Drug Administration ukuze isetshenziswe ezigulini zezingane ezine-graft versus host disease (cGVHD) ezingaphansi konyaka ongu-1 ubudala futhi ezihlulekile umugqa owodwa noma ngaphezulu we-systemic therapy. Isixazululo somlomo, amaphilisi, nama-capsules yizibonelo zokwakheka.
Ukusebenza kwe-Ibrutinib kwahlolwa ku-iMAGINE (NCT03790332), ilebula evulekile, ephakathi nendawo, yengalo eyodwa yezingane kanye nabantu abadala abasebasha abane-cGVHD emaphakathi noma eqinile. Abahlanganyeli babeneminyaka esukela kowonyaka ukuya ngaphansi kweminyaka engama-1. Iziguli ezingama-22 zazidinga ukwelashwa okwengeziwe ngemva kokuba umugqa owodwa noma ngaphezulu wemithi ye-systemic uhlulekile futhi zabhaliswa ocwaningweni. Uma ukubandakanyeka kwe-genitourinary esithweni esisodwa kwakuwukuphela kwesibonakaliso se-cGVHD, iziguli zazingafakwa.
Isilinganiso seminyaka yesiguli sasiyiminyaka eyi-13 (uhla, 1 kuya ku-19). Lokhu okulandelayo ngezinye zezibalo zeziguli ezingama-47: u-70% wabantu besilisa, u-36% ngabaMhlophe, u-9% ngoMnyama noma u-Afrika waseMelika, kanti u-55% awubikwanga.
Isilinganiso sokuphendula sisonke (ORR) kuya Evikini lama-25 sisebenze njengenkomba yomphumela wokuphumelela oyinhloko. Ngokwemibandela Yokuphendula Iphrojekthi Ye-NIH Yokuthuthukisa I-2014, i-ORR ihlanganisa izimpendulo ezigcwele noma ezingaphelele. Ngeviki lama-25, i-ORR yayisifinyelele ku-60% (95% CI: 44, 74). Isikhathi esijwayelekile esithathiwe ukuze kunikezwe impendulo kwakuyizinyanga ezingu-5.3 (95% CI: 2.8, 8.8). Ubude besikhathi obumaphakathi be-cGVHD bebuyizinyanga eziyi-14.8 (95% CI: 4.6, akunakulinganiswa) kusukela ekuphenduleni kokuqala kokufa noma ukwelashwa okusha kwesistimu.
I-anemia, ubuhlungu be-musculoskeletal, i-pyrexia, isifo sohudo, inyumoniya, ubuhlungu besisu, i-stomatitis, i-thrombocytopenia, kanye nekhanda elibuhlungu kwakuyizehlakalo ezimbi kakhulu (20%), njenge-pyrexia, isifo sohudo, inyumoniya, ubuhlungu besisu kanye ne-stomatitis.
Umthamo onconyiwe we-IMBRUVICA ngu-420 mg ngomlomo kanye ngosuku ezigulini ezineminyaka engu-12 ubudala nangaphezulu ezine-cGVHD kanye no-240 mg/m2 ngomlomo kanye ngosuku (kufika kumthamo wama-420 mg) ezigulini ezineminyaka engu-1 kuye ngaphansi kweminyaka engu-12 ubudala ezine-cGVHD. , kuze kube yilapho i-cGVHD iqhubeka, ukuvela kabusha kwesifo esiyingozi, noma ubuthi obungamukeleki.
Buka imininingwane egcwele ye-Imbruvica.
