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FLT3-D835 (TKD) in newly-diagnosed AML: midostaurin + 7+3 was studied in FLT3-mutant (ITD...

Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.

IDBMA-FLT3-D835-AML
TypeActionability
Statusreviewed 2026-04-27 | pending_clinical_signoff | actionability review required
DiseasesDIS-AML
SourcesSRC-CIVIC SRC-ELN-AML-2022 SRC-NCCN-AML-2025 SRC-RATIFY-STONE-2017

Actionability Facts

BiomarkerBIO-FLT3-D835
VariantTKD point mutation (D835Y/V/H/F; ~7% AML, often co-occurs with ITD)
DiseaseDIS-AML
ESCAT tierIB
Recommended combinationsmidostaurin + 7+3 + HiDAC consolidation + midostaurin maintenance, consider gilteritinib (off-label intensification or post-induction maintenance, trial)
Contraindicated monotherapyquizartinib monotherapy (inactive vs D835 — type II FLT3i; QuANTUM-First label is FLT3-ITD only)
Evidence summaryFLT3-D835 (TKD) in newly-diagnosed AML: midostaurin + 7+3 was studied in FLT3-mutant (ITD or TKD) AML in RATIFY (Stone 2017) — benefit driven primarily by ITD subset, with smaller magnitude in TKD. Quizartinib (type II FLT3i) is INACTIVE against TKD D835 (target alternate conformation). Gilteritinib (type I) and midostaurin retain activity. ELN 2022 prognostic impact of D835 alone is intermediate.

Notes

ESCAT IB. OncoKB Level 1. Critical TKI-selection point: D835 confers resistance to type II FLT3i (quizartinib, sorafenib) but NOT to type I FLT3i (gilteritinib, midostaurin, crenolanib). Companion diagnostic: LeukoStrat CDx detects both ITD and TKD D835.

Used By

No reverse references found in the YAML corpus.