{"entity":{"id":"quizartinib","kind":"drug","name":"Quizartinib","aka":[],"tldr":"Quizartinib is a more selective FLT3 blocker that, added to chemotherapy, roughly doubled median survival in the highest-risk FLT3 subtype.","summary":"QuANTUM-First (n=539, FLT3-ITD, age 18-75): median OS 31.9 vs 15.1 months (HR 0.776), including patients not transplanted; benefit sustained in the maintenance phase analysis. Approved July 2023 with a boxed warning for QT prolongation and a REMS. Earlier rejected (2019) in the relapsed setting after QuANTUM-R despite a positive OS result. Approved in Japan 2019.","status":"approved","asOf":"2026-09-07","wikipedia":"https://en.wikipedia.org/wiki/Quizartinib","links":[{"label":"FDA label (DailyMed)","url":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?query=Quizartinib"}],"tags":[],"related":["flt3-itd"],"cancers":["aml","aml-flt3"],"sections":[],"technologies":["kinase-inhibitors"],"targets":["flt3"],"drugs":[],"companies":["daiichi-sankyo"],"institutions":[],"pathways":[],"terms":[],"trials":["quantum-first","nct06824168","nct03793478"],"people":[],"bottlenecks":[],"keyPapers":[],"journals":[],"dependsOn":[],"notes":[],"brand":"Vanflyta","modality":"Small-molecule kinase inhibitor (FLT3-ITD, type II)","mechanism":"Type II FLT3 inhibitor binding the inactive DFG-out conformation; potent against ITD, inactive against TKD resistance mutations (D835).","approvals":[{"region":"US","year":2023,"indication":"Newly diagnosed FLT3-ITD AML with 7+3, consolidation, and maintenance"},{"region":"Japan","year":2019,"indication":"Relapsed/refractory FLT3-ITD AML"}],"mechanismSteps":["Quizartinib locks FLT3-ITD in its inactive conformation","Downstream STAT5 and MAPK signalling is silenced","FLT3-ITD blasts undergo apoptosis while normal progenitors are spared","Continued for up to 36 cycles of maintenance after consolidation or transplant"],"dosing":{"route":"Oral","schedule":"35.4 mg once daily on days 8-21 of induction and consolidation; 26.5 mg daily for 2 weeks then 53 mg daily as maintenance for up to 36 cycles","monitoring":"ECG at baseline and regularly (boxed warning: QT prolongation, torsades); electrolytes; REMS","source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Vanflyta"},"toxicity":[{"event":"QT prolongation","source":"https://dailymed.nlm.nih.gov/dailymed/search.cfm?labeltype=all&query=Vanflyta","note":"Boxed warning; grade 3 QTc >500 ms in ~3%"},{"event":"Febrile neutropenia","grade3PlusPct":43},{"event":"Neutropenia","grade3PlusPct":20,"note":"Prolonged count recovery during consolidation"},{"event":"Hypokalaemia","anyGradePct":32}],"access":[],"regulatoryEvents":[{"date":"2019-06-14","type":"crl","region":"US","note":"Complete response letter for relapsed/refractory indication (QuANTUM-R)"},{"date":"2023-07-20","type":"approval","region":"US","note":"Frontline FLT3-ITD AML (QuANTUM-First)"}]},"route":"/drugs/quizartinib/","neighbours":{"biomarker":[{"id":"flt3-itd","kind":"biomarker","name":"FLT3-ITD (internal tandem duplication)","route":"/biomarkers/flt3-itd/"},{"id":"flt3-tkd","kind":"biomarker","name":"FLT3-TKD (D835 and I836 tyrosine kinase domain mutations)","route":"/biomarkers/flt3-tkd/"}],"cancer":[{"id":"aml","kind":"cancer","name":"Acute myeloid leukaemia","route":"/cancers/aml/"},{"id":"aml-older-unfit","kind":"cancer","name":"Acute myeloid leukaemia in older or unfit patients","route":"/cancers/aml-older-unfit/"},{"id":"aml-flt3","kind":"cancer","name":"FLT3-mutated acute myeloid leukaemia","route":"/cancers/aml-flt3/"}],"technology":[{"id":"kinase-inhibitors","kind":"technology","name":"Small-molecule kinase inhibitors","route":"/technologies/kinase-inhibitors/"}],"target":[{"id":"flt3","kind":"target","name":"FLT3","route":"/targets/flt3/"},{"id":"stat5","kind":"target","name":"STAT5 (STAT5A, STAT5B)","route":"/targets/stat5/"}],"company":[{"id":"daiichi-sankyo","kind":"company","name":"Daiichi Sankyo","route":"/companies/daiichi-sankyo/"}],"trial":[{"id":"nct06824168","kind":"trial","name":"Evaluation of Two Dose Levels of Quizartinib as Maintenance in FLT3-ITD (+) Acute Myeloid Leukemia Patients in Complete Remission","route":"/trials/nct06824168/"},{"id":"quantum-first","kind":"trial","name":"QuANTUM-First","route":"/trials/quantum-first/"},{"id":"nct03793478","kind":"trial","name":"Safety and Efficacy of Quizartinib in Children and Young Adults With Acute Myeloid Leukemia (AML), a Cancer of the Blood","route":"/trials/nct03793478/"}],"pairing":[{"id":"flt3i-plus-7-3","kind":"pairing","name":"FLT3 inhibitor + intensive chemotherapy","route":"/pairings/flt3i-plus-7-3/"}],"paper":[{"id":"paper-admiral-gilteritinib-flt3-nejm-2019","kind":"paper","name":"ADMIRAL: gilteritinib pills versus chemotherapy for relapsed FLT3-mutated acute myeloid leukaemia","route":"/key-papers/paper-admiral-gilteritinib-flt3-nejm-2019/"},{"id":"paper-quantum-first-quizartinib-lancet-2023","kind":"paper","name":"QuANTUM-First: quizartinib added to intensive chemotherapy and continued as maintenance in newly diagnosed FLT3-ITD AML","route":"/key-papers/paper-quantum-first-quizartinib-lancet-2023/"}],"pathway":[{"id":"aml-signalling","kind":"pathway","name":"Acute myeloid leukaemia (KEGG map)","route":"/pathways/aml-signalling/"}]}}