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FLT3-ITD is a duplicated stretch of the FLT3 receptor gene found in about a quarter of acute myeloid leukaemias; it makes relapse more likely and is treated with midostaurin, quizartinib or gilteritinib.
Internal tandem duplications in the juxtamembrane domain are detected by PCR fragment analysis (the LeukoStrat CDx FLT3 Mutation Assay reports ITD and the TKD mutations D835 and I836) or by sequencing; the allelic ratio once used in ELN risk stratification was dropped in ELN 2022. Midostaurin (Rydapt) is labelled for newly diagnosed FLT3 mutation-positive AML with induction and consolidation chemotherapy; quizartinib (Vanflyta, 2023) specifically for FLT3-ITD-positive newly diagnosed AML including maintenance; gilteritinib (Xospata) for relapsed or refractory AML with a FLT3 mutation. All three name an FDA-approved test, and the LeukoStrat assay is the companion diagnostic for each.
In plain words · FLT3 is a kinase mutated in about a third of acute myeloid leukaemias, where adding an inhibitor to chemotherapy improves survival.
A FLT3-ITD result at diagnosis means a FLT3 inhibitor (midostaurin or quizartinib) is added to chemotherapy from the first cycle, and it strengthens the case for a stem cell transplant in first remission. If the leukaemia comes back, gilteritinib tablets are on label. The test must be back within days, so ask that it be sent at diagnosis.
Written only from the label or guideline text cited on this page. Not medical advice; your own report and the reading your team gives it come first.
An internal tandem duplication in FLT3 exons 14 to 15 detected by PCR fragment analysis (LeukoStrat CDx) or sequencing of blood or marrow; the assay's positivity uses a signal ratio cut-off of 0.05.
“ITD mutations and TKD mutations D835 and I836”
FDA: List of FDA-Authorized Companion Diagnostic Devices| Threshold | Drug | Cancer | Regulator | Source |
|---|---|---|---|---|
| FLT3-ITD-positive | Quizartinib | FLT3-mutated acute myeloid leukaemia | FDA | label |
| FLT3 mutation-positive (ITD or TKD) | Midostaurin | FLT3-mutated acute myeloid leukaemia | FDA | label |
| FLT3 mutation (ITD or TKD), relapsed or refractory | Gilteritinib | FLT3-mutated acute myeloid leukaemia | FDA | label |
| Device | Maker | Indication and sample | Drug | PMA / 510(k) |
|---|---|---|---|---|
| LeukoStrat CDx FLT3 Mutation Assay | Invivoscribe Technologies | Acute Myelogenous Leukemia - Peripheral Blood or Bone Marrow | Midostaurin | P160040 (04/28/2017) |
| LeukoStrat CDx FLT3 Mutation Assay | Invivoscribe Technologies | Acute Myelogenous Leukemia - Peripheral Blood or Bone Marrow | Gilteritinib | P160040/S002 (11/28/2018) |
| LeukoStrat CDx FLT3 Mutation Assay | Invivoscribe Technologies | Acute Myeloid Leukemia (AML) - Peripheral Blood or Bone Marrow | Quizartinib | P160040/S011 (07/20/2023) |
Matched on the name and aliases of the readout in the title, setting and summary of each trial; a match is a mention, not proof the readout was an entry criterion.
Shares Quizartinib, Midostaurin, Gilteritinib, FLT3.
Shares Quizartinib, Midostaurin, Gilteritinib, FLT3.
Shares Quizartinib, Midostaurin, Gilteritinib, FLT3.
Shares FLT3-ITD allelic ratio, Midostaurin, FLT3, FLT3-mutated acute myeloid leukaemia.
Shares Quizartinib, Midostaurin, Gilteritinib, FLT3.
Shares NPM1 mutation, Acute myeloid leukaemia and the tag biomarker.
Shares FLT3, Acute myeloid leukaemia and the tag flt3.
Shares Midostaurin, FLT3, Acute myeloid leukaemia.