2022 yil iyun: Ivosidenib (Tibsovo, Servier Pharmaceuticals MChJ) in combination with azacitidine has been approved by the Food and Drug Administration for newly diagnosed acute myeloid leukaemia (AML) in adults 75 years or older with a susceptible IDH1 mutation, as detected by an FDA-approved test, or who have comorbidities that prevent intensive induction chemotherapy.
The FDA granted approval based on the results of a randomised, multicenter, double-blind, placebo-controlled study (AG120-C-009, NCT03173248) that enrolled 146 patients with newly diagnosed AML with an IDH1 mutation who satisfied at least one of the following criteria: age 75 years or older, ECG performance status 2, significant cardiac or pulmonary disease, hepatic impairment with bilirubin > 1.5 times the upper limit of normal, creatinine clearance 45 mL/min, or other comorbidities On Days 1-28, patients were randomised 1:1 to receive ivosidenib 500 mg daily (N=72) or a matched placebo orally once daily (N=74) in combination with azacitidine 75 mg/m2/day on Days 1-7 or Days 1-5 and 8-9 of each 28-day cycle until disease progression, unacceptable toxicity, or hematopoietic stem cell transplantation until disease progression, unacceptable toxicity, or hematopoietic stem cell transplantation
Hodisasiz omon qolish (EFS), umumiy omon qolish (OS) va to'liq remissiya tezligi va davomiyligini yaxshilash samaradorlikni (CR) aniqlash uchun ishlatilgan. Randomizatsiyadan davolash muvaffaqiyatsizligi, remissiyadan qaytalanish yoki biron bir sababdan o'limgacha bo'lgan davr, qaysi biri birinchi bo'lib kelganidan qat'i nazar, EFS deb ataladi. 24 hafta ichida CR ga erisha olmaslik davolash muvaffaqiyatsizligi deb hisoblanadi. EFS ivosidenib plyus azatsitidinli bemorlarning 65 foizida va platsebo va azatsitidinli bemorlarning 84 foizida kuzatilgan (HR 0.35; 95 foiz CI: 0.17, 0.72, p=0.0038). Ivosidenib plyus azatsitidin qo'lida o'rtacha operatsion tizim 24.0 oyni tashkil etdi (95 foiz CI: 11.3, 34.1), platsebo va azatitidin qo'lida esa 7.9 oy (95 foiz CI: 4.1, 11.3) (HR 0.44; 95 foiz CI: 0.27; p=0.73). Ivosidenib plyus azasitidin qo'lida CR darajasi 0.0010 foizni (47 foiz CI: 95 foiz, 35 foiz) va platsebo va azatitidin qo'lida 59 foizni (15 foiz CI: 95 foiz, 8 foiz) tashkil etdi. Ivosidenib plyus azasitidin qo'lida CR ning o'rtacha davomiyligini platsebo va azasitidin qo'lida (SH) (25 foiz ishonch oralig'i: 95, NE) va 13.0 oy (11.2 foiz ishonch oralig'i: 95, SH) baholab bo'lmaydi.
Diareya, charchoq, shish, ko'ngil aynishi, qusish, ishtahaning pasayishi, leykotsitoz, artralgiya, nafas qisilishi, qorin og'rig'i, shilliq qavatning yallig'lanishi, toshma, elektrokardiyogramda QT ning uzayishi, differentsiatsiya sindromi va miyalgiya ivosiak monoterapiyasi yoki ivosiapid bilan kombinatsiyalanganda eng ko'p uchraydigan nojo'ya reaktsiyalar edi. (har qanday sinovda 25 foiz). Retsept bo'yicha ko'rsatmalar bo'yicha o'rnatilgan ogohlantirish sog'liqni saqlash mutaxassislari va bemorlarni o'limga olib keladigan yoki hayot uchun xavfli bo'lishi mumkin bo'lgan differentsiatsiya sindromi ehtimoli haqida ogohlantiradi.
Ivosidenib kuniga bir marta 500 mg dozada, oziq-ovqat bilan yoki ovqatlanmasdan, kasallikning kuchayishi yoki qabul qilinishi mumkin bo'lmagan toksiklik paydo bo'lguncha buyuriladi. Har bir 1 kunlik tsiklning 7-1 kunlarida (yoki 5-8 va 9-28 kunlarida) ivosidenibni azatitidin bilan birgalikda kuniga bir marta 75 mg/m2 teri ostiga yoki tomir ichiga yuborishni boshlang. Kasallikning kuchayishi yoki sezilarli toksikligi bo'lmagan bemorlarga klinik javobga vaqt berish uchun kamida 6 oy davolash tavsiya etiladi.
Tibsovo uchun to'liq retsept ma'lumotlarini ko'ring
