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FLT3-mutated acute myeloid leukaemia carries a mutation in a growth-signal receptor that makes the leukaemia relapse quickly. Adding a FLT3 blocker to chemotherapy, midostaurin or quizartinib, lengthens life, and gilteritinib is the standard when the disease comes back.
FLT3 is a receptor tyrosine kinase on blood stem cells. An internal tandem duplication (ITD) in about a quarter of adult AML, or a point mutation in the tyrosine kinase domain (TKD) in under a tenth, keeps it switched on. FLT3-ITD leukaemias present with high white counts and relapse early, and the ELN 2022 classification places them in the intermediate-risk group whatever the allelic ratio, so an allogeneic transplant in first remission is usually recommended. Testing for FLT3 must return within days because the inhibitor is started with the first chemotherapy cycle.
RATIFY, reported in 2017, randomised 717 patients aged 18 to 59 to midostaurin or placebo added to 7+3 induction, consolidation and a year of maintenance: median overall survival rose from 25.6 to 74.7 months (hazard ratio 0.78), and midostaurin became the first targeted drug approved in AML that year. QuANTUM-First extended the approach to FLT3-ITD patients up to 75 with the more selective quizartinib: median survival 31.9 versus 15.1 months (hazard ratio 0.776), approved in 2023. For relapsed or refractory FLT3-mutated disease, ADMIRAL showed single-agent gilteritinib beat salvage chemotherapy, median survival 9.3 versus 5.6 months (hazard ratio 0.64), and it was approved in 2018.
The open questions are which inhibitor to pair with intensive chemotherapy, whether FLT3 inhibitor maintenance after transplant should be universal or MRD-guided (MORPHO found the gilteritinib benefit concentrated in patients with detectable FLT3-ITD before or after transplant), how to combine FLT3 inhibitors with venetoclax and azacitidine in unfit patients, and how to treat the resistance mutations and clonal switches that follow each drug.
Averages across everyone diagnosed, often years ago. A median is the middle of a group: half the people counted lived longer than the figure shown, and some lived far longer. Your stage, subtype, age, fitness and the treatment you receive matter more than the average, and the numbers are improving quickly.
About three in ten adults with acute myeloid leukaemia carry a FLT3 mutation, most often the internal tandem duplication, which used to mark one of the worst outlooks in the disease.
Leukaemias, myeloma and MDS live in the marrow and blood; lymphomas grow in lymph nodes and spleen. The node stations are the disease map, not a route of spread, and staging counts them.
In lymphoma the node stations are the disease itself; staging (Ann Arbor / Lugano) counts how many regions and sides of the diaphragm are involved.
Same organ: High-grade B-cell lymphoma with MYC and BCL2 rearrangements (double-hit lymphoma), Mediastinal grey zone lymphoma, Primary effusion lymphoma, Plasmablastic lymphoma, T-cell/histiocyte-rich large B-cell lymphoma, EBV-positive diffuse large B-cell lymphoma, Primary large B-cell lymphoma of the testis, Gastric MALT lymphoma, Ocular adnexal MALT lymphoma, Extranodal NK/T-cell lymphoma, Adult T-cell leukaemia/lymphoma, ALK-positive anaplastic large cell lymphoma, ALK-negative anaplastic large cell lymphoma, Breast implant-associated anaplastic large cell lymphoma, Primary cutaneous anaplastic large cell lymphoma, Lymphomatoid papulosis, Mycosis fungoides, Enteropathy-associated T-cell lymphoma, Monomorphic epitheliotropic intestinal T-cell lymphoma, Extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue (MALT lymphoma), Splenic marginal zone lymphoma, Nodal marginal zone lymphoma, Primary cutaneous marginal zone lymphoma, Primary cutaneous follicle centre lymphoma, Sezary syndrome, Nodal T-follicular helper cell lymphoma, angioimmunoblastic type (angioimmunoblastic T-cell lymphoma), Hepatosplenic T-cell lymphoma, Intravascular large B-cell lymphoma, Lymphomatoid granulomatosis, T-cell prolymphocytic leukaemia, Splenic B-cell lymphoma/leukaemia with prominent nucleoli (formerly B-cell prolymphocytic leukaemia and hairy cell leukaemia variant), T-cell large granular lymphocytic leukaemia, Mixed-phenotype acute leukaemia, Myeloid leukaemia of Down syndrome, Burkitt leukaemia, Marginal zone lymphoma, Cutaneous T-cell lymphoma (mycosis fungoides and Sezary syndrome), Primary mediastinal (thymic) large B-cell lymphoma, Leukaemia (all types), Acute myeloid leukaemia, Acute lymphoblastic leukaemia, Chronic lymphocytic leukaemia, Chronic myeloid leukaemia (CML), Diffuse large B-cell lymphoma, Follicular lymphoma, Hodgkin lymphoma, Mantle cell lymphoma, Multiple myeloma, Non-Hodgkin lymphoma (all types), Myelodysplastic syndromes / neoplasms (MDS), Myeloproliferative neoplasms (PV, ET, myelofibrosis), Polycythaemia vera (PV), Essential thrombocythaemia (ET), Waldenström macroglobulinaemia, Hairy cell leukaemia, Peripheral T-cell lymphomas (including cutaneous T-cell lymphoma), Blastic plasmacytoid dendritic cell neoplasm (BPDCN), Burkitt lymphoma, HIV-associated (AIDS-related) lymphomas, Chronic myelomonocytic leukaemia and MDS/MPN overlap neoplasms, Systemic mastocytosis, Erdheim-Chester disease, Rosai-Dorfman disease and other histiocytic neoplasms, Langerhans cell histiocytosis (LCH), Post-transplant lymphoproliferative disorder (PTLD), IDH1- and IDH2-mutated acute myeloid leukaemia, NPM1-mutated and KMT2A-rearranged acute myeloid leukaemia, Secondary and therapy-related acute myeloid leukaemia, Acute promyelocytic leukaemia, Acute myeloid leukaemia in older or unfit patients, Smouldering multiple myeloma, Newly diagnosed multiple myeloma, transplant-eligible, Newly diagnosed multiple myeloma, transplant-ineligible, Relapsed or refractory multiple myeloma, Plasma cell leukaemia, Lower-risk myelodysplastic syndromes, Higher-risk myelodysplastic syndromes, Chronic lymphocytic leukaemia, first treatment, Relapsed or refractory chronic lymphocytic leukaemia, Richter transformation of chronic lymphocytic leukaemia, Chronic myeloid leukaemia, chronic phase, Chronic myeloid leukaemia, accelerated and blast phase, Primary myelofibrosis, Standard-risk B-cell acute lymphoblastic leukaemia in children, High-risk acute lymphoblastic leukaemia in children (high-risk B-ALL and T-ALL), Philadelphia chromosome-positive acute lymphoblastic leukaemia in children (Ph-positive ALL), Philadelphia chromosome-like acute lymphoblastic leukaemia (Ph-like or BCR::ABL1-like ALL), Infant acute lymphoblastic leukaemia (KMT2A-rearranged, under one year), Relapsed and refractory acute lymphoblastic leukaemia in children, Acute myeloid leukaemia in children, Erdheim-Chester disease, Rosai-Dorfman-Destombes disease, Single-system Langerhans cell histiocytosis (bone, skin or one other organ), Multisystem Langerhans cell histiocytosis (with or without risk-organ involvement), Indolent and smouldering systemic mastocytosis, Advanced systemic mastocytosis (aggressive SM, SM with an associated haematological neoplasm, mast cell leukaemia), Early-stage classical Hodgkin lymphoma (stage I to II), Advanced-stage classical Hodgkin lymphoma (stage III to IV), Nodular lymphocyte-predominant Hodgkin lymphoma (nodular lymphocyte-predominant B-cell lymphoma), Relapsed and refractory classical Hodgkin lymphoma
7+3 induction with midostaurin (RATIFY) or, for FLT3-ITD, quizartinib (QuANTUM-First), then consolidation and maintenance with the same inhibitor; allogeneic transplant in first remission for most FLT3-ITD patients.
Venetoclax plus azacitidine, with a FLT3 inhibitor added in trials or where labelled; gilteritinib with azacitidine is an option.
Gilteritinib alone (ADMIRAL) as a bridge to allogeneic transplant; quizartinib where approved for relapse; FLT3 inhibitor maintenance after transplant.
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Post-transplant FLT3 inhibitor maintenance helps patients with detectable FLT3-ITD residual disease and can probably be spared in those without it; guidelines now describe maintenance for MRD-positive disease on this evidence.
QuANTUM-First gave FLT3-ITD AML patients a second front-line targeted option and showed that continuing a FLT3 inhibitor as long-term maintenance, including after transplant, pays off. Quizartinib was approved for this indication in 2023. Head-to-head data against midostaurin are lacking, and the design leaves open how much of the benefit came from maintenance.
The risk category on an AML report, and therefore whether a patient is steered towards transplant in first remission, comes from these recommendations.
ADMIRAL showed that a targeted oral drug can beat chemotherapy outright in relapsed AML, and made gilteritinib the standard bridge to transplant for FLT3-mutated relapse. Its success also underpinned FLT3 inhibitor use in first-line combinations. Resistance through FLT3-independent clones and RAS pathway mutations limits durability without transplant.
FLT3 testing at diagnosis and a FLT3 inhibitor during chemotherapy became standard. Quizartinib (QuANTUM-First) is an alternative for FLT3-ITD, and the approach extended FLT3 inhibitors into maintenance and relapse.
Query for this cancer: (TITLE:"FLT3-mutated acute myeloid leukaemia" OR ABSTRACT:"FLT3-mutated acute myeloid leukaemia" OR TITLE:"FLT3-ITD AML" OR ABSTRACT:"FLT3-ITD AML" OR TITLE:"FLT3-TKD AML" OR ABSTRACT:"FLT3-TKD AML" OR TITLE:"FLT3-positive AML" OR ABSTRACT:"FLT3-positive AML") AND (treatment OR therapy OR trial OR survival OR diagnosis). Results are unfiltered search hits about FLT3-mutated acute myeloid leukaemia, not a curated reading list.
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Fainting, near-fainting, or an irregular or racing heartbeat; several kinase inhibitors prolong the QT interval and the labels require ECG and electrolyte monitoring.
Bleeding that does not stop by itself, bleeding from more than one site, or new bruising in several places or one large area.
Nausea, vomiting, muscle cramps, palpitations, seizures, confusion or passing much less urine in the first days of a new dose; the label requires hydration, anti-hyperuricaemic drugs and blood tests around each ramp-up step.
QT: both Quizartinib and Gilteritinib prolong the QT interval (known and known risk).. Boxed warning: QT prolongation, torsades and cardiac arrest. Do not start if QTcF above 450 ms; avoid QT-prolonging drugs; REMS programme.
Take with food; antiemetic prophylaxis.
Take with a meal and water. Avoid grapefruit, Seville oranges and starfruit.
See all on the product pages:AzacitidineCytarabine + anthracycline ('7+3')GilteritinibMidostaurinQuizartinibVenetoclax·Printable cards in the navigator
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