Avgust 2021: Tivozanib (Fotivda, AVEO Pharmaceuticals, Inc.), Kinaz inhibitori, ikki yoki undan ko'p tizimli terapiyadan so'ng, relapsli yoki refrakter rivojlangan buyrak hujayrali karsinomasi (RCC) bo'lgan kattalar bemorlari uchun FDA tomonidan tasdiqlangan.
TIVO-3 (NCT02627963), a randomised (1:1), open-label, multicenter trial of tivozanib versus sorafenib in patients with relapsed or refractory advanced RCC who had received two or three prior systemic treatments, including at least one VEGFR kinase inhibitor other than sorafenib or tivozanib, was used to assess efficacy. Patients were given either tivozanib 1.34 mg orally once daily for 21 consecutive days every 28 days or sorafenib 400 mg orally twice a day until disease progression or intolerable toxicity, whichever came first.
Progression-free survival (PFS) was the primary efficacy outcome measure, which was reviewed by a blinded independent radiological review committee. Overall survival (OS) and objective response rate were two other effectiveness objectives (ORR).
Tivozanib qo'lidagi o'rtacha PFS (n = 175) 5.6 oyni (95 % CI: 4.8, 7.3), sorafenib qo'lidagi 3.9 oy (95 % CI: 3.7, 5.6) (HR 0.73; 95 % CI: 0.56, 0.95; p = 0.016). Tivozanib va sorafenib guruhlari uchun o'rtacha OS mos ravishda 16.4 oy (95 foiz CI: 13.4, 21.9) va 19.2 oy (95 foiz CI: 14.9, 24.2) (HR 0.97; 95 foiz CI: 0.75, 1.24). Tivozanib qo'lining ORR darajasi 18 foizni (95 foiz CI: 12 foiz, 24 foiz) va sorafenib bilagi uchun 8 foizni (95 foiz CI: 4 foiz, 13 foiz) tashkil etdi.
Charchoq, gipertoniya, diareya, ishtahaning pasayishi, ko'ngil aynishi, disfoniya, hipotiroidizm, yo'tal va stomatit eng ko'p (20%) salbiy ta'sir ko'rsatdi. Natriyning kamayishi, lipazning ko'payishi va fosfatning kamayishi laboratoriya anomaliyalarining eng keng tarqalgani 3 yoki 4 darajali (5%) edi.
Tavsiya etilgan tivozanib dozasi kuniga bir marta (ovqat bilan yoki ovqatlanmasdan) 1.34 kun davomida 21 mg ni tashkil qiladi, so'ngra kasallik rivojlanmaguncha yoki chidab bo'lmas toksiklikka qadar 28 kunlik tanaffus.
Malumot: https://www.fda.gov/
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