Gilteritinib
Deterministic view of the source YAML entity. Clinical authority remains with the cited source IDs and reviewer sign-off state.
| ID | DRUG-GILTERITINIB |
|---|---|
| Type | Drug |
| Aliases | XospataГілтеритиніб |
| Status | reviewed 2026-04-25 | pending_clinical_signoff |
| Diseases | DIS-AML |
| Sources | SRC-ELN-AML-2022 SRC-NCCN-AML-2025 |
Drug Facts
| Class | Selective FLT3 + AXL tyrosine kinase inhibitor (Type I) |
|---|---|
| Mechanism | Type-I FLT3 inhibitor active against both FLT3-ITD and FLT3-TKD (D835) mutations, including activation-loop mutations that confer resistance to Type-II FLT3 inhibitors (quizartinib, sorafenib). Also inhibits AXL (proposed FLT3-TKI resistance mechanism). Approved on the basis of ADMIRAL trial (single-agent vs salvage chemotherapy in R/R FLT3-mutated AML). |
| Typical dosing | 120 mg PO once daily, continuous, until disease progression or unacceptable toxicity. Dose modifications for QTc prolongation, differentiation syndrome, posterior reversible encephalopathy syndrome (PRES), pancreatitis. Take with or without food. |
| Ukraine registered | False |
| NSZU reimbursed | False |
| Ukraine last verified | 2026-04-27 |
Warnings
- Differentiation syndrome — fatal if not recognized; corticosteroids + dose interruption mandatory
- PRES (posterior reversible encephalopathy syndrome) — discontinue if confirmed
- QTc prolongation — baseline + serial ECG; correct K+/Mg++
Notes
Pivotal trial: ADMIRAL (Perl et al., NEJM 2019) — single-agent gilteritinib vs investigator-choice salvage chemo in R/R FLT3-mutated AML; median OS 9.3 vs 5.6 mo (HR 0.64). Standard 2L+ for R/R FLT3-mutated AML. Type-I selectivity covers both FLT3-ITD and FLT3-TKD/D835 mutations (advantage vs Type-II quizartinib which misses TKD). Ukraine: NOT registered, NOT reimbursed — major access barrier; international referral or EAP Astellas Ukraine compassionate-use pathway required. Differentiation syndrome (3-5%) is the signature AE — mandate corticosteroid hold + supportive care; rechallenge after resolution.
Used By
Regimens
REG-GILTERITINIB-AML- Gilteritinib monotherapy for R/R FLT3-mutated AML