Birlashgan Qirollik Qinlokni (ripretinib) GISTning toʻrtinchi-qatorini davolashni maʼqulladi va u Xitoyda ishga tushirildi!

Zai Lab hamkori Deciphera Pharmaceuticals yaqinda Britaniya Dorilar va Sog'liqni saqlash mahsulotlari boshqarmasi (MHRA) maqsadli saratonga qarshi Qinlock preparatini tasdiqlaganligini e'lon qildi.ripretinib) gastrointestinal stromal o'smasi (GIST) bo'lgan kattalardagi bemorlarni davolashning to'rtinchi-yo'nalishi uchun. Qinlock quyidagilar uchun javob beradi: ilgari 3 yoki undan ko'p kinaz inhibitörlerini (shu jumladan,) olgan rivojlangan GIST bo'lgan kattalar bemorlari.imatinib). Faza 3 INVICTUS tadqiqotida Qinlock davolash kasallikning rivojlanishi yoki o'lim xavfini 85 foizga sezilarli darajada kamaytirdi va klinik jihatdan muhim umumiy omon qolish foydasini ko'rsatdi.

Ripetinib KIT/PDGFR kinaz almashinuvi regulyatori inhibitori bo‘lib, KIT/PDGFR -qo‘zg‘atuvchi oshqozon-ichak stromal o‘smalari (GIST), tizimli mastotsitoz (SM) va boshqa saratonlarni davolashda qo‘llaniladi. 2019 yil iyun oyida Zai Lab Deciphera'dan Buyuk Xitoyda (Xitoy, Gonkong, Makao va Tayvan) Repetinibni rivojlantirish va targ'ib qilish uchun eksklyuziv litsenziyani oldi.

2021-yil mart oyida Qinlock Xitoyning Milliy Tibbiy Mahsulotlar Boshqarmasi (NMPA) tomonidan 3 yoki undan ortiq kinaz inhibitörleri, shu jumladan imatinib bilan davolangan rivojlangan GISTli katta yoshli bemorlarni davolash uchun tasdiqlangan. 2021 yil mart oyida Qinlok Gonkong Sog'liqni saqlash departamenti tomonidan ham tasdiqlangan.

Steve Hoerter, President and CEO of Deciphera, said: "For patients with advanced GIST in the UK who have been waiting for new treatment options, the approval of Qinlock is an important milestone. The results of the INVICTUS study emphasize the potential of Qinlock to transform the treatment of advanced GIST. Establish a new standard of care for the UK's fourth-line GIST."

Buyuk Britaniyada MHRA Qinlockni 3-bosqich INVICTUS tadqiqotining asosiy tahlilining samaradorlik natijalari, shuningdek, INVICTUS tadqiqoti va 1-bosqich tadqiqotining xavfsizlik natijalari asosida tasdiqladi. INVICTUS randomizatsiyalangan (2:1), ikki{4}}koʻr, platsebo{5}}nazorat ostidagi 3-bosqich tadqiqoti boʻlib, unda ilgari bir nechta terapiya (shu jumladan, kamida) olgan jami 129 nafar bemor ishtirok etadi.imatinib, sunitinib, regorafenib)) GIST rivojlangan bemorlarda Qinlokning platseboga nisbatan samaradorligi va xavfsizligi baholandi.

2019-avgustda e’lon qilingan asosiy tahlil natijalari tadqiqot asosiy yakuniy nuqtaga yetganligini ko‘rsatdi: platsebo guruhi bilan solishtirganda, Qinlock davolash guruhi sezilarli darajada uzoqroq davom etdi{1}}erkin omon qolish (o‘rtacha PFS: 6,3 oy). 1,0 oyga nisbatan), kasallikning rivojlanishi yoki o'lim xavfi 85 foizga sezilarli darajada kamayadi (HR=0.15, p<0.0001). in="" terms="" of="" secondary="" endpoint="" overall="" survival="" (os),="" the="" qinlock="" treatment="" group="" was="" significantly="" longer="" than="" the="" placebo="" group="" (median="" os:="" 15.1="" months="" vs="" 6.6="" months),="" and="" the="" risk="" of="" death="" was="" reduced="" by="" 64%="" (hr="0.36," nominal="" p="0.0004)" );="" it="" is="" worth="" noting="" that="" the="" os="" data="" in="" the="" placebo="" group="" includes="" data="" on="" patients="" who="" switched="" to="" qinlock="" treatment="" after="" receiving="" placebo="" treatment.="" the="" overall="" response="" rate="" (orr)="" of="" another="" secondary="" endpoint="" was="" significantly="" improved="" in="" the="" qinlock="" treatment="" group="" compared="" with="" the="" placebo="" group="" (orr:="" 9.4%="" vs="" 0%,="" p="">

The latest analysis results announced at the ESMO meeting in 2020 showed that patients who switched from placebo to open-label Qinlock treatment had a median PFS of 4.6 months and a median OS of 11.6 months. These data further strengthen Qinlock's potential to provide meaningful clinical benefits to patients with advanced GIST. For GIST patients who have previously received three treatment options, Qinlock represents a new standard of care.

INVICTUS tadqiqot natijalari

Qinlock's active pharmaceutical ingredient is ripretinib, KIT/PDGFR kinaz almashinuvi regulyatori inhibitori bo'lib, KIT/PDGFR -qo'zg'atuvchi oshqozon-ichak stromal o'smalari (GIST), tizimli mastotsitoz (SM) va boshqa saraton kasalliklarini davolash uchun ishlatiladi.ripretinibKIT va PDGFR ning keng spektrli mutatsiyalarini inhibe qilish orqali gastrointestinal stromal o'smalari bo'lgan bemorlarni davolashni yaxshilash uchun maxsus ishlab chiqilgan. Ripretinib 9, 11, 13, 14, 17 va 18-eksonlardagi boshlang'ich va ikkilamchi KIT mutatsiyalarini oshqozon-ichak stromal o'smalarida va SM Sub D816V mutatsiyasida topilgan №17 birlamchi KIT eksonini bloklashi mumkin. Ripretinib shuningdek, 12, 14 va 18-eksonlarda birlamchi PDGFR mutatsiyalarini, shu jumladan 18-eksondagi D842V mutatsiyasini o'z ichiga olgan oshqozon-ichak stromal o'smalarini inhibe qiladi.

2020-yil may oyida Qinlock AQSH FDA tomonidan ilgʻor GISTni toʻrtinchi-davolash uchun tasdiqlangan. Qinlock ilgari 3 yoki undan ortiq kinaz inhibitörlerini olgan kattalar bemorlari uchun javob beradi, jumladan:imatinib, sunitinib, regorafenib.

Qayd etish joizki, Qinlock GISTni to'rtinchi{0}}davolash uchun tasdiqlangan birinchi yangi dori bo'lib, hayajonli bosqichni belgilab beradi. GIST - oshqozon-ichak traktidan kelib chiqadigan o'sma. Dastlab an'anaviy tirozin kinaz inhibitörlerine javob beradigan bemorlarning ko'pchiligi ikkinchi darajali mutatsiyalar tufayli o'smaning rivojlanishini rivojlantiradi. Faza III INVICTUS tadqiqotida Qinlock progressivlik-erkin omon qolish (PFS) va umumiy omon qolish (OS) nuqtai nazaridan ishonchli klinik davolash afzalliklarini ko'rsatdi va yaxshi xavfsizlik va bardoshlilikka ega. Dori to'rtta bo'ladi Line GIST asosiy yangi terapiyani ta'minlaydi.

In approving Qinlock, Richard Pazdur, MD, Director of the FDA Oncology Center of Excellence and Acting Director of the Office of Oncology and Diseases of the FDA's Center for Drug Evaluation and Research, spoke highly of: "Although there has been progress in the development of GIST treatments over the past 20 years, including Four FDA-approved targeted therapies-imatinib 2002, sunitinib 2006, regorafenib 2013, avapritinib avapritinib, 2020— —But some patients did not respond to treatment and the tumor continued to progress. Qinlock's approval for marketing provides a new treatment option for patients who have exhausted the FDA-approved GIST treatment methods."(