Agusta 2021: Dostarlimab-gxly (Jemperli, GlaxoSmithKline LLC) sun sami karɓuwa daɗaɗawa daga Hukumar Abinci da Magunguna don manya marasa lafiya waɗanda ke da ƙarancin gyara gyare-gyare (dMMR) maimaituwa ko ci gaba da ciwon daji na endometrial, kamar yadda gwajin da FDA ta amince da shi, waɗanda suka ci gaba akan ko bayan tsarin da ya ƙunshi platinum na baya.
A cikin Gwajin GARNET (NCT02715284), multicenter, multicohort, gwajin lakabin budewa a cikin marasa lafiya da ci gaba da ciwace-ciwacen ciwace-ciwacen ƙwayoyi, an kimanta tasiri dangane da ƙungiyar (A1). 71 marasa lafiya tare da dMMR mai maimaitawa ko ci gaba da ciwon daji na endometrial wanda ya ci gaba a kan ko bayan jiyya mai dauke da platinum an haɗa su a cikin yawan inganci. An ba marasa lafiya 500 MG na dostarlimab-gxly a cikin intravenously kowane mako uku don allurai hudu, sannan 1,000 MG a cikin jini kowane mako shida.
Yawan amsa gabaɗaya (ORR) da tsawon lokacin amsawa (DOR) sune sakamako na farko na inganci, kamar yadda aka ƙaddara ta hanyar nazari na tsakiya mai zaman kansa (BICR) daidai da RECIST 1.1. An tabbatar da ORR zuwa kashi 42.3 (kashi 95 na CI: 30.6 bisa dari, kashi 54.6). Adadin martanin ya kasance kashi 12.7 bisa 29.6 don cikakkun martani da kashi 93.3 bisa dari don martanin da bai cika ba. Tare da kashi 2.6 na marasa lafiya da ke da tsawon lokaci na kasa da watanni shida, ba a cika DOR na tsakiya ba (kewaye: 22.4 zuwa watanni XNUMX, mai gudana a kima na ƙarshe).
In 34 percent of individuals who received dostarlimab-gxly, serious side effects occurred. Sepsis, acute renal injury, urinary tract infection, abdominal discomfort, and pyrexia were among the serious adverse responses experienced by more than 2% of patients. Fatigue/asthenia, nausea, diarrhoea, anaemia, and constipation were the most prevalent side effects (20%). Anemia and elevated transaminases were the most common grade 3 or 4 adverse events (2%). Pneumonitis, colitis, hepatitis, endocrinopathies, and nephritis are all immune-mediated adverse responses that might occur.
Kuna so karanta: Maganin ciwon daji a Indiya
Dostarlimab-gxly 500 mg kowane mako 3 shine shawarar da aka ba da shawarar kashi da jadawalin (masu allurai 1 zuwa 4). An fara makonni uku bayan sashi na 4, ana ƙara yawan allurai zuwa 1,000 MG kowane mako shida har sai cutar ta ci gaba ko rashin haƙuri. Ya kamata a isar da Dostarlimab-gxly azaman jiko na mintuna 30.
Magana: https://www.fda.gov/
Duba cikakkun bayanai nan.
