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| Molecular Profile | FLT3 D835X |
| Therapy | Gilteritinib |
| Indication/Tumor Type | acute myeloid leukemia |
| Response Type | sensitive |
| Molecular Profile | Indication/Tumor Type | Response Type | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|
| FLT3 D835X | acute myeloid leukemia | sensitive | Gilteritinib | FDA approved - On Companion Diagnostic | Actionable | In a Phase III trial (ADMIRAL) that supported FDA approval, Xospata (gilteritinib) improved median overall survival (9.3 vs 5.6 mo, HR. 0.64, p<0.001) compared to chemotherapy, resulted in superior median event-free survival (2.8 vs 0.7 mo, HR 0.79) and rate of complete remission with full or partial hematologic recovery (34.0% vs 15.3%) in patients with relapsed or refractory acute myeloid leukemia harboring a FLT3 internal tandem duplication (ITD), D835, or I836 mutation (PMID: 31665578; NCT02421939). | detail... 31665578 detail... |
| PubMed Id | Reference Title | Details |
|---|---|---|
| Full reference... | ||
| Xospata (gilteritinib) FDA Drug Label | Full reference... | |
| (31665578) | Gilteritinib or Chemotherapy for Relapsed or Refractory FLT3-Mutated AML. | Full reference... |