August 2023: Daawaynta bukaanada qaangaarka ah ee qaba cudurka 'myeloid leukemia' (AML) ee dhowaan la helay oo ah FLT3 nuqul ka mid ah tandem gudaha (ITD) -positive, sida lagu ogaaday baaritaanka FDA-ansixisay, oo leh cytarabine caadiga ah iyo induction anthracycline iyo xoojinta cytarabine, iyo sidoo kale dayactirka monotherapy ka dib isku darka kemotherabi, waxaa ansixiyay Maamulka Cuntada iyo Dawooyinka.
LeukoStrat CDx FLT3 Mutation Assay ayaa sidoo kale la siiyay oggolaanshaha FDA sida ogaanshaha saaxiibka Vanflyta.
In QuANTUM-First (NCT02668653), a randomised, double-blind, placebo-controlled trial involving 539 patients with newly diagnosed FLT3-ITD positive AML, the effectiveness of quizartinib in combination with chemotherapy was assessed. A tijaabada caafimaadka assay was used to establish the FLT3-ITD status prospectively, and the companion diagnostic LeukoStrat CDx FLT3 Mutation Assay was used to confirm it after the fact.
Marka loo eego shaqada bilowga ah, bukaannada ayaa la kala soocay (1: 1) si ay u helaan quizartinib (n = 268) ama placebo (n = 271) oo leh induction, xoojinta, iyo dayactirka monotherapy. Bilowgii daawaynta xoojinta ka dib, ma jirin dib-u- randomization. Ka dib soo kabashada unugyada unugyada unugyada dhiigga cas (HSCT), bukaannada maray HSCT waxay bilaabeen daawaynta dayactirka.
Guud ahaan badbaadada (OS), laga soo bilaabo taariikhda randomization ilaa dhimashada sabab kasta, ayaa u adeegay sidii qiyaasta natiijada waxtarka aasaasiga ah. Ka dib markii ugu yaraan 24 bilood ka soo wareegtay tan iyo markii bukaankii ugu dambeeyay si aan kala sooc lahayn loo qoondeeyay, falanqaynta weyn ayaa la sameeyay. Tijaabada, cududda quizartinib waxay muujisay koror tirakoob oo muhiim ah OS [khatarta (HR) 0.78; 95% CI: 0.62, 0.98; 2 dhinac p=0.0324]. Muddada dhexdhexaadka ah ee bilaha 38.6 (95% CI: 21.9, NE), heerka quizartinib cududda CR wuxuu ahaa 55% (95% CI: 48.7, 60.9), iyo kooxda placebo ee CR waxay ahayd 55% (95% CI: 49.2) , 61.4) oo leh dhexdhexaad dhexdhexaad ah bilaha 12.4 (95% CI: 8.8, 22.7).
Ka dib allogeneic HSCT, quizartinib laguma talinayo sida monotherapy dayactirka ah. Quiartinib looma muujin inuu ku kordhinayo OS xaaladan.
Kordhinta QT, torsades de pointes, iyo wadne istaaga ayaa dhamaantood lagu sheegay digniinta sanduuqa ee quizartinib. Kaliya Vanflyta REMS, oo ah barnaamij xaddidan oo hoos imanaya Istaraatiijiyada Qiimaynta iyo Khatarta (REMS), ayaa bixisa quizartinib. Si aad u hesho liis dhammaystiran oo waxyeellooyin ah, la tasho macluumaadka laguu qoray.
Qiyaasta quizartinib ee lagu taliyey waa sida soo socota:
- Induction: 35.4 mg afka hal mar maalintii maalmaha 8-21 ee "7 + 3" (cytarabine [100 ama 200 mg / m2 / maalin] maalmaha 1 ilaa 7 oo lagu daray daunorubicin [60 mg / m2 / maalin] ama idarubicin [12 mg /m2/maalintii] maalmaha 1 ilaa 3) iyo maalmaha 8-21 ama 6-19 ee soo gelista labaad ee ikhtiyaarka ah ("7 + 3" ama "5 + 2" [5 maalmood cytarabine iyo 2 maalmood daunorubicin ama idarubicin], siday u kala horreeyaan),
- b) Isku-dubarid: 35.4 mg afka hal mar maalin maalmaha 6-19 ee qiyaasta sare ee cytarabine (1.5 ilaa 3 g/m2 12 saacadood kasta maalmaha 1, 3 iyo 5) ilaa 4 wareegyo, iyo
- c) Dayactirka: 26.5 mg afka hal mar maalin maalmaha 1 ilaa 14 iyo 53 mg hal mar maalintii, ka dib, ilaa soddon iyo lix wareegyada 28-maalmood.
U fiirso macluumaadka qoritaanka oo buuxa ee Vanflyta
