FLT3-D835 (TKD) in newly-diagnosed AML: midostaurin + 7+3 was studied in FLT3-mutant (ITD...
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| ID | BMA-FLT3-D835-AML |
|---|---|
| Type | Pertinence thérapeutique |
| État | reviewed 2026-04-27 | pending_clinical_signoff | actionability review required |
| Maladies | DIS-AML |
| Sources | SRC-CIVIC SRC-ELN-AML-2022 SRC-NCCN-AML-2025 SRC-RATIFY-STONE-2017 |
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| Biomarqueur | BIO-FLT3-D835 |
|---|---|
| Variante | TKD point mutation (D835Y/V/H/F; ~7% AML, often co-occurs with ITD) |
| Maladie | DIS-AML |
| Niveau ESCAT | IB |
| Combinaisons recommandées | midostaurin + 7+3 + HiDAC consolidation + midostaurin maintenance, consider gilteritinib (off-label intensification or post-induction maintenance, trial) |
| Contre-indiqué en monothérapie | quizartinib monotherapy (inactive vs D835 — type II FLT3i; QuANTUM-First label is FLT3-ITD only) |
| Résumé des faits | FLT3-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.
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