Avgust 2021: Dostarlimab-gxly (Jemperli, GlaxoSmithKline MChJ) FDA tomonidan tasdiqlangan test orqali aniqlangan, nomutanosiblikni tuzatish nuqsoni (dMMR) takroriy yoki rivojlangan endometrium saratoni bilan og'rigan, oldingi platina o'z ichiga olgan rejimda yoki undan keyin rivojlangan kattalar bemorlari uchun oziq-ovqat va farmatsevtika idorasidan tezlashtirilgan ruxsat oldi.
GARNET sinovida (NCT02715284), rivojlangan qattiq o'smalari bo'lgan bemorlarda ko'p markazli, ko'p kohort, ochiq yorliqli sinovda samaradorlik kohortga (A1) qarab baholandi. Platinani o'z ichiga olgan davolashda yoki undan keyin rivojlangan dMMR takroriy yoki rivojlangan endometrium saratoni bo'lgan 71 bemor samaradorlik populyatsiyasiga kiritilgan. Bemorlarga 500 mg dostarlimab-gxly tomir ichiga har uch haftada to'rt dozada, so'ngra har olti haftada 1,000 mg tomir ichiga yuborildi.
Umumiy javob tezligi (ORR) va javob davomiyligi (DOR) RECIST 1.1 ga muvofiq ko'r -ko'rona mustaqil markaziy tekshiruv (BICR) tomonidan aniqlangan asosiy samaradorlik natijalari edi. ORR 42.3 foiz (95 foiz CI: 30.6 foiz, 54.6 foiz) ekanligini tasdiqladi. To'liq javoblar uchun javob darajasi 12.7 foiz, to'liq bo'lmagan javoblar uchun 29.6 foizni tashkil etdi. Olti oydan kam davom etadigan bemorlarning 93.3 foizi o'rtacha DORga erishmagan (diapazon: 2.6 dan 22.4 oygacha, oxirgi baholashda davom etmoqda).
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.
Siz o'qishni xohlashingiz mumkin: Hindistonda saraton kasalligini davolash
Dostarlimab-gxly 500 mg har 3 haftada-tavsiya etilgan doz va jadval (1 dan 4 gacha dozalar). 4 -dozadan keyin uch hafta o'tgach, dozasi har 1,000 haftada 30 mg gacha oshiriladi, kasallik kuchayib ketguncha yoki chidab bo'lmas toksiklik bilan. Dostarlimab-gxly XNUMX daqiqalik tomir ichiga infuziya shaklida yuborilishi kerak.
Malumot: https://www.fda.gov/
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