Dec 2022: Atezolizumab (Tecentriq, Genentech, Inc.) an amince da shi ta Cibiyar Abinci da Magunguna (FDA) ga manya da marasa lafiya na yara tare da sarcoma mai laushi mara kyau ko metastatic alveolar mai laushi waɗanda ke da shekaru 2 ko fiye (ASPS).
A cikin Nazarin ML39345 (NCT03141684), alamar buɗewa, binciken hannu guda ɗaya wanda ya shafi manya da marasa lafiya na yara 49 tare da metastatic ko ASPS wanda ba a iya ganewa, an kimanta ingancin inganci. Matsayin aikin ECOG na 2 kuma ta hanyar tarihi ko cytologically an tabbatar da ASPS wanda ba za a iya warkewa ta hanyar tiyata ba sune abubuwan da ake buƙata don cancanta. An hana marasa lafiya idan suna da ciwon daji na farko na tsakiya (CNS) ko alamun bayyanar cututtuka na CNS, cututtukan hanta na asibiti, tarihin tsara ciwon huhu, ciwon huhu, ko ciwon huhu mai aiki akan hoto. Marasa lafiya na yara sun sami 15 mg/kg (har zuwa matsakaicin 1200 MG) ta cikin jijiya sau ɗaya a cikin kwanaki 21 har sai rashin lafiya ya ci gaba ko rashin haƙuri. Manya marasa lafiya sun sami 1200 MG a cikin jini.
Yawan amsa gabaɗaya (ORR) da tsawon lokacin amsawa (DOR), waɗanda kwamitin bita mai zaman kansa ya ƙaddara ta amfani da RECIST v1.1, sune matakan sakamako na farko na inganci. (95% CI: 13, 39), ORR ya kasance 24%. Kashi 12 cikin 42 na marasa lafiya XNUMX da suka sami amsa na haƙiƙa suna da DOR na watanni shida ko fiye, kuma kashi XNUMX cikin ɗari suna da DOR na watanni goma sha biyu ko fiye.
Matsakaicin shekarun masu haƙuri shine shekaru 31 (yanayin shine 12-70); akwai 47 manya marasa lafiya (2% daga cikinsu sun wuce 65 shekaru) da 2 marasa lafiya na yara (shekaru 12); 51% na marasa lafiya mata ne; 55% sun kasance Fari; 29% Bakaken fata ne ko Ba'amurke; kuma 10% na Asiya ne.
Mafi yawan halayen haɗari (15%) sune ciwon tsoka (67%), gajiya (55%), rash, tari, tashin zuciya, ciwon kai, da hauhawar jini (43% kowanne), maƙarƙashiya, dyspnea, dizziness, da hemorrhage (29%). kowanne), rage cin abinci da arrhythmia (22% kowanne), rashin lafiya kamar mura, asarar nauyi, da rashin lafiyar rhinitis anaphylaxis (18% kowanne).
Ya kamata majinyata manya su dauki atezolizumab a kashi na 840 MG kowane mako biyu, 1200 MG kowane mako uku, ko 1680 MG kowane mako hudu har sai cutar ta su ta ci gaba ko kuma illar da ke tattare da ita ta zama mai iya jurewa. Yara masu shekaru 2 da haihuwa ya kamata su sami 15 mg/kg (har zuwa 1200 MG) kowane mako 3 har sai yanayin ya ci gaba ko kuma akwai rashin iya jurewa.
View full prescribing information for Tecentriq.
