Avgust 2022: FDA tomonidan tasdiqlangan testda aniqlanganidek, o'smalari mezenximal-epitelial o'tish (MET) 14 eksonini o'tkazib yuborishga olib keladigan mutatsiyaga ega bo'lgan metastatik kichik hujayrali bo'lmagan o'pka saratoni (KHDAK) bo'lgan katta yoshli bemorlarga oziq-ovqat va farmatsevtika idorasi kapmatinib (Tabrecta) berdi. , Novartis Pharmaceuticals Corp.) muntazam tasdiqlash.
GEOMETRY mono-1 sinovida (NCT02414139) koʻp markazli, tasodifiy boʻlmagan, ochiq yorliqli, koʻp kohort tadqiqotida dastlabki umumiy javob tezligi va javob davomiyligiga asoslanib, may oyida kapmatinibga xuddi shu koʻrsatkich uchun tezlashtirilgan ruxsat berilgan edi. 6, 2020. Qo'shimcha 63 bemor ma'lumotlari va javobning chidamliligini baholash va terapevtik foydani tasdiqlash uchun qo'shimcha 22 oylik kuzatuv ma'lumotlari asosida muntazam tasdiqlashga o'tkazildi.
METning 160-eksonini o'tkazib yuboradigan mutatsiyaga ega rivojlangan NSCLC bilan og'rigan 14 nafar bemor samaradorlikni ko'rsatdi. Bemorlar kasallik kuchayguncha yoki nojo'ya ta'sirlar chidab bo'lmas holga kelguncha kuniga ikki marta 400 mg kapmatinib olgan.
Ko'r bo'lmagan mustaqil ko'rib chiqish qo'mitasi asosiy samaradorlik choralari (BIRC) sifatida ORR va javob muddatini (DOR) aniqladi. Hech qachon davolanmagan 60 kishida ORR 68% (95% CI: 55, 80) va DOR 16.6 oy (95% CI: 8.4, 22.1) edi. Ilgari davolangan 44 bemor orasida ORR 95% (34% CI: 54, 100) va DOR 9.7 oy (95% CI: 5.6, 13) ni tashkil etdi.
The patients’ average age was 71 years (48 to 90). The following specific demographics were reported: 61% female, 77% White, 61% never smoked, 83% had adenokarsinoma, and 16% had metastases to the central nervous system. 81% of patients who had previously had treatment had only gotten one line of systemic therapy; 16% had received two; and 3% had received three. 86% of patients who had previously had treatment had platinum-based chemotherapy.
Bemorlarda shish, ko'ngil aynishi, mushak-skelet tizimining og'rig'i, charchoq, qusish, nafas qisilishi, yo'tal va ishtahaning pasayishi (20%) eng ko'p uchraydi.
Kapmatinibni kuniga ikki marta 400 mg dozada, ovqat bilan yoki ovqatlanmasdan ichish kerak.
Tabrecta uchun to'liq retsept ma'lumotlarini ko'ring