August 2023: Kurapa kwevarwere vakura vane acute myeloid leukemia (AML) ichangobva kuwanikwa inonzi FLT3 yemukati tandem duplication (ITD) -positive, sezvakaonekwa neFDA-yakatenderwa bvunzo, ine yakajairwa cytarabine uye anthracycline induction uye cytarabine consolidation, pamwe nekuchengetedza. monotherapy inotevera kusanganisa chemotherapy, yakabvumidzwa neFood and Drug Administration.
LeukoStrat CDx FLT3 Mutation Assay yakapihwawo mvumo yeFDA semumwe Vanflyta mufambidzani wekuongorora.
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 kliniki yekuedzwa 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.
Zvinoenderana nebasa rekutanga, varwere vaive vakasarudzika (1: 1) kuti vagamuchire quizartinib (n = 268) kana placebo (n = 271) ine induction, consolidation, uye kuchengetedza monotherapy. Pakutanga kwe-post-consolidation therapy, pakanga pasina re-randomization. Mushure mekupora kwehematopoietic stem cell transplantation (HSCT), varwere vakaita HSCT vakatanga kurapwa.
Kupona kwese (OS), yakaverengerwa kubva pazuva rekusarongeka kusvika parufu kubva kune chero chikonzero, yakashanda seyekutanga kushanda kwemhedzisiro chiyero. Mushure mokunge mwedzi ye24 yapfuura kubva apo murwere wekupedzisira akagoverwa zvisina kurongwa, kuongorora kukuru kwakaitwa. Mukutongwa, ruoko rwequizartinib rwakaratidza kuwedzera kwenhamba ye OS [hazard ratio (HR) 0.78; 95% CI: 0.62, 0.98; 2 yakaganhurwa p=0.0324]. Nenguva yepakati yemwedzi 38.6 (95% CI: 21.9, NE), chiyero che quizartinib arm's CR chaiva 55% (95% CI: 48.7, 60.9), uye CR rate yeboka re placebo yaiva 55% (95% CI: 49.2 , 61.4) ine nguva yepakati yemwedzi 12.4 (95% CI: 8.8, 22.7).
Kutevera allogeneic HSCT, quizartinib haina kukurudzirwa sekuchengetedza monotherapy. Quiartinib haina kuratidzwa kuwedzera OS mumamiriro ezvinhu aya.
QT kureba, torsades de pointes, uye kusungwa kwemoyo zvese zvinotaurwa mubhokisi yambiro yequizartinib. Chete Vanflyta REMS, chirongwa chakarambidzwa pasi peRisk Evaluation uye Mitigation Strategy (REMS), inopa quizartinib. Kuti uwane runyoro rwakakwana rwemigumisiro yechirwere, bvunza ruzivo rwakanyorwa.
Iyo yakakurudzirwa quizartinib dose yakaita seinotevera:
- Induction: 35.4 mg muromo kamwe chete pazuva paMazuva 8-21 e "7 + 3" (cytarabine [100 kana 200 mg / m2 / zuva] paMazuva 1 kusvika ku7 pamwe ne daunorubicin [60 mg / m2 / zuva] kana idarubicin [12 mg /m2/day] paMazuva 1 kusvika ku3) uye paMazuva 8-21 kana 6-19 esarudzo yechipiri induction ("7 + 3" kana "5 + 2" [5 mazuva cytarabine pamwe ne2 mazuva daunorubicin kana idarubicin], zvichiteerana),
- b) Kubatanidza: 35.4 mg muromo kamwe chete pazuva paMazuva 6-19 e-high-dose cytarabine (1.5 kusvika 3 g / m2 maawa gumi nemaviri paMazuva 12, 1 uye 3) kusvika ku5 kutenderera, uye
- c) Maintenance: 26.5 mg muromo kamwe chete zuva nezuva paMazuva 1 kusvika ku14 uye 53 mg kamwe chete zuva nezuva, pashure pacho, kusvika kune makumi matatu nematanhatu 28-day cycles.
Wona ruzivo rwakazara rwekurayira Vanflyta
