Avgust 2021: FDA tezlashtirilgan ruxsatnomani berdi sotorasib (Lumakras ™, Amgen, Inc.), RAS GTPase oilasi inhibitori, FDA tomonidan tasdiqlangan test bilan aniqlangan kamida bir marta tizimli terapiya olgan KRAS G12C mutatsiyaga uchragan mahalliy rivojlangan yoki metastatik kichik hujayrali bo'lmagan o'pka saratoni (KHDAK) bo'lgan kattalar bemorlari uchun.
Lumakras uchun diagnostika sifatida FDA QIAGEN therascreen® KRAS RGQ PCR to'plamini (to'qima) va Guardant360® CDx (plazma) ni tasdiqladi. Agar plazma namunasida mutatsiya aniqlanmasa, o'simta to'qimasini baholash kerak.
The approval was based on CodeBreaK 100, a multicenter, single-arm, open label clinical study (NCT03600883) that included patients with KRAS G12C mutations who had locally progressed or metastatic NSCLC. The efficacy of the drug was tested in 124 patients whose disease had progressed on or after at least one previous systemic therapy. Sotorasib 960 mg orally once a day was given to patients until disease progression or intolerable toxicity.
Asosiy samaradorlik natijalari ko'r -ko'rona o'tkazilgan mustaqil markaziy tekshiruv bilan aniqlangan RECIST 1.1 bo'yicha ob'ektiv javob tezligi (ORR) va javob davomiyligi edi. O'rtacha javob vaqti 10 oy (diapazon 1.3+, 11.1) bilan ORR 36 foizni tashkil etdi (95 foiz CI: 28 foiz, 45 foiz).
Diareya, mushak -skelet tizimining og'rig'i, ko'ngil aynishi, charchash, gepatotoksiklik va yo'tal eng ko'p ko'rilgan yon ta'sirlar edi (20%). Limfotsitlarning kamayishi, gemoglobinning kamayishi, aspartat aminotransferazaning ko'payishi, alanin aminotransferazasining ko'payishi, kaltsiyning pasayishi, ishqoriy fosfatazaning ko'payishi, siydik oqsilining ko'payishi va natriyning kamayishi laboratoriya anormalliklari orasida eng ko'p uchraydigan anomaliyalar edi (25 foiz).
Sotorasib kuniga bir marta, ovqat bilan yoki ovqatsiz, 960 mg dozada qabul qilinadi.
960 mg dozasi mavjud klinik dalillar, shuningdek, bu miqdorni tasdiqlovchi farmakokinetik va farmakodinamik simulyatsiyalar asosida tasdiqlangan. FDA, pastroq dozaning ham xuddi shunday terapevtik ta'sirga ega bo'lishini tekshirish uchun, tezlashtirilgan tasdiqlashning bir qismi sifatida, postmarketing sinovini talab qilmoqda.
Malumot: https://www.fda.gov/
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