August 2021: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) yakapihwa mvumo yekukurumidza neKudya neDrug Administration kwevakuru varwere vane mismatch kugadzirisa kushomeka (dMMR) inodzokororwa kana yakakwira mamota yakasimba, sekusarudzwa nemuedzo unobvumidzwa neDFA, wakafambira mberi kana kutevera kurapwa kwekutanga uye vasina imwe inogutsa sarudzo.
VENTANA MMR RxDx Panel yakagoneswawo neiyo FDA nhasi seimwe shamwari yekuongorora kifaa kune varwere vane dMMR tumarara twakasimba avo vari kurapwa ne dostarlimab-gxly.
Iyo GARNET Kuedza (NCT02715284), isiri-yakasarudzika, multicenter, yakavhurika-chitambi, yakawanda-cohort kutongwa, yakatarisa kushanda kwe dostarlimab. Hwehuwandu hwehuwandu hwaisanganisira varwere makumi maviri nevapfumbamwe vane dMMR inodzokororwa kana mapundu akasimba akasimba avo vakafambira mberi mushure mehurongwa hwehurongwa uye vasina dzimwe sarudzo.
Yakazara mhinduro (ORR) uye nguva yekupindura (DoR) yaive mibairo mikuru yekubudirira, sekugadzwa kwekupofumadza yakazvimirira yepakati ongororo maererano neRECIST 1.1. Iine 9.1 muzana mhinduro yakakwana uye 32.5 muzana chikamu chekupindura, iyo ORR yaive 41.6 muzana (95 muzana CI: 34.9, 48.6). Iyo yepakati DOR yaive mwedzi 34.7 (renji 2.6 kusvika 35.8+), uye 95.4 muzana yevarwere vaive neDOR isingasviki mwedzi mitanhatu.
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.
Dostarlimab inopihwa seinopinda intravenous pamusoro pemaminitsi makumi matatu vhiki nhatu dzese dzeyadhi imwe chete kusvika ina. Dosing inowedzerwa kusvika ku30 mg masvondo matanhatu ese kutanga mavhiki matatu mushure mekuyerwa 1,000.
Dheuteronomio: https://www.fda.gov/
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