Disemba 2022: I-Atezolizumab (Tecentriq, Genentech, Inc.) igunyazwe i-Food and Drug Administration (FDA) yeziguli zabantu abadala kanye nezingane ezinengxenye ethambile ye-alveolar engabukeki noma ye-metastatic alveolar esineminyaka engu-2 ubudala noma ngaphezulu (ASPS).
Ocwaningweni lwe-ML39345 (NCT03141684), ilebula evulekile, ucwaningo lwengalo eyodwa olubandakanya iziguli ezingama-49 zabantu abadala kanye nezingane ezine-ASPS ye-metastatic noma engalungiseki, ukusebenza kahle kuye kwahlolwa. Isimo sokusebenza se-ECOG se-2 kanye ne-ASPS efakazelwe ngokomlando noma ngokwe-cytologically engelapheki ngokuhlinzwa kwakuyizimfuneko zokufaneleka. Iziguli zazingafaneleki uma zinomdlavuza oyinhloko wesistimu yezinzwa (CNS) noma izimpawu ze-CNS metastases, ukugula kwesibindi okubalulekile emtholampilo, umlando wokuhlela inyumoniya, i-pneumonitis, noma i-pneumonitis esebenzayo ekucabangeni. Iziguli zezingane zithole i-15 mg/kg (kufika ku-1200 mg) ngomthambo we-intravenously kanye njalo ezinsukwini ezingama-21 kuze kube yilapho ukugula kuqhubeka noma ubuthi obungabekezeleleki. Iziguli zabantu abadala zithole i-1200 mg nge-intravenously.
Isilinganiso sokuphendula sisonke (ORR) kanye nobude besikhathi sokuphendula (DOR), okunqunywe ikomiti elibuyekezayo elizimele lisebenzisa i-RECIST v1.1, kwakuyizinyathelo eziyinhloko zomphumela wokusebenza ngempumelelo. (95% CI: 13, 39), i-ORR yayingu-24%. Amaphesenti angamashumi ayisithupha nesikhombisa eziguli ze-12 ezazinempendulo ehlosiwe zine-DOR yezinyanga eziyisithupha noma ngaphezulu, kanti amaphesenti angu-42 ane-DOR yezinyanga eziyishumi nambili noma ngaphezulu.
Iminyaka yobudala yesiguli yayiyiminyaka engu-31 (ububanzi bebungu-12-70); bekuneziguli zabantu abadala ezingama-47 (ama-2% azo abengaphezulu kweminyaka engama-65) kanye neziguli ezi-2 zezingane (ezineminyaka eyi-12); Ama-51% eziguli kwakungabesifazane; Ama-55% ayengabaMhlophe; Ama-29% kwakungabantu abamnyama noma base-Afrika baseMelika; futhi amaphesenti angu-10 ayengama-Asia.
Ukusabela okungekuhle kakhulu (15%) kwakuwubuhlungu bemisipha namathambo (67%), ukukhathala (55%), ukuqubuka, ukukhwehlela, isicanucanu, ikhanda elibuhlungu, nomfutho wegazi ophakeme (43% ngamunye), ukuqunjelwa, ukuphefumula, isiyezi, ukopha (29%). ngayinye), ukuncipha kwesifiso sokudla kanye ne-arrhythmia (22% ngayinye), ukugula okufana nomkhuhlane, ukuncipha kwesisindo, kanye ne-allergenic rhinitis anaphylaxis (18% ngayinye).
Iziguli ezikhulile kufanele ziphuze i-atezolizumab ngesilinganiso esingu-840 mg njalo emavikini amabili, 1200 mg njalo emavikini amathathu, noma 1680 mg njalo emavikini amane kuze kube yilapho isifo sazo siqhubeka noma imiphumela engemihle ingabekezeleleki. Izingane ezineminyaka engu-2 nangaphezulu kufanele zithole u-15 mg/kg (kufika ku-1200 mg) njalo emavikini ama-3 kuze kube yilapho isimo siqhubeka noma kunobuthi obungabekezeleleki.
View full prescribing information for Tecentriq.
