August 2021: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) inikezwe ukugunyazwa okusheshayo yi-Food and Drug Administration ezigulini ezikhulile ezinenkinga yokulungisa ukungafani (i-dMMR) eziphindaphindayo noma eziqinile eziqinile, njengoba kunqunywe ukuhlolwa okugunyazwe yi-FDA, okuqhubeke noma kulandela ukwelashwa kwangaphambili futhi ezingenakho okunye ukwelashwa okwanelisayo. ongakhetha kukho.
Iphaneli ye-VENTANA MMR RxDx nayo yagunyazwa yi-FDA namuhla njengethuluzi lokuxilonga elihambisana neziguli ezine-dMMR izimila eziqinile ezilashwa nge-dostarlimab-gxly.
I-GARNET Experiment (NCT02715284), okungahleliwe, okumaphakathi, ilebula evulekile, isivivinyo samaqembu amaningi, sibheke ukusebenza kahle kwe-dostarlimab. Inani labantu abaphumelelayo lalihlanganisa iziguli ezingama-209 ezine-dMMR eziphindaphindayo noma ezithuthukile eziqinile ezazithuthuke ngemva kokwelashwa kwesistimu futhi zazingenazo ezinye izinketho.
Isilinganiso sokuphendula sisonke (ORR) kanye nobude besikhathi sokuphendula (i-DoR) kube yimiphumela emikhulu yokusebenza ngempumelelo, njengoba kusungulwe ukubuyekezwa okuzimele okuphuphuthekisiwe ngokuhambisana ne-RECIST 1.1. Ngesilinganiso sokuphendula esiphelele esingamaphesenti angu-9.1 kanye nezinga lokuphendula lengxenye elingamaphesenti angu-32.5, i-ORR yayingamaphesenti angu-41.6 (amaphesenti angu-95 CI: 34.9, 48.6). I-DOR emaphakathi yayiyizinyanga ezingu-34.7 (ububanzi obungu-2.6 kuya ku-35.8+), kanti amaphesenti angu-95.4 eziguli ayene-DOR engaphansi kwezinyanga ezingu-6.
Fatigue/asthenia, anaemia, diarrhoea, and nausea are the most prevalent side responses in individuals with dMMR solid tumours (20 percent). Anemia, fatigue/asthenia, elevated transaminases, sepsis, and acute renal injury were the most prevalent Grade 3 or 4 adverse events (2%). Pneumonitis, colitis, hepatitis, endocrinopathies, nephritis, and dermatologic toxicity are all immune-mediated adverse events associated with dostarlimab-gxly.
I-Dostarlimab inikezwa njengokufakwa emthanjeni imizuzu engama-30 njalo emasontweni amathathu ngemithamo eyodwa ukuya kweyesine. Umthamo unyuswa ube ngu-1,000 mg njalo emavikini ayi-6 kusukela emavikini ama-3 ngemuva komthamo wesi-4.
Izikhombo: https://www.fda.gov/
Bheka imininingwane lapha.
