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Molecular Profile FLT3 exon 15 ins
Therapy Quizartinib
Indication/Tumor Type acute myeloid leukemia
Response Type sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FLT3 exon 15 ins acute myeloid leukemia sensitive Quizartinib FDA approved - On Companion Diagnostic Actionable In a Phase III trial (QuANTUM-First) that supported FDA approval, Vanflyta (quizartinib) in combination with induction and consolidation chemotherapy, followed by Vanflyta (quizartinib) maintenance improved median overall survival (31.9 vs 15.1 months, HR 0.78, p=0.032) compared to placebo in patients with newly-diagnosed acute myeloid leukemia harboring FLT3 internal tandem duplication (ITD; exon 14 insertion, exon 15 insertion) (PMID: 37116523; NCT02668653). detail... detail... 37116523
FLT3 exon 15 ins acute myeloid leukemia sensitive Quizartinib Guideline Actionable Vanflyta (quizartinib) is included in guidelines as maintenance therapy for patients with acute myeloid leukemia harboring a FLT3 internal tandem duplication (FLT3-ITD) mutation (NCCN.org). detail...
PubMed Id Reference Title Details
NCCN.org Full reference...
Full reference...
Vanflyta (quizartinib) FDA Drug Label Full reference...
(37116523) Quizartinib plus chemotherapy in newly diagnosed patients with FLT3-internal-tandem-duplication-positive acute myeloid leukaemia (QuANTUM-First): a randomised, double-blind, placebo-controlled, phase 3 trial. Full reference...