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| Profile Name | FLT3 D835del |
| Gene Variant Detail | |
| Relevant Treatment Approaches | FLT3 Inhibitor |
| Molecular Profile | Indication/Tumor Type | Response Type | Relevant Treatment Approaches | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|---|
| FLT3 D835del | acute myeloid leukemia | sensitive | FLT3 Inhibitor | Cytarabine + Daunorubicin + Midostaurin | FDA approved - On Companion Diagnostic | Actionable | In a Phase III trial that supported FDA approval, treatment with Rydapt (midostaurin), combined with Cytosar-U (cytarabine) and Daunorubicin, improved overall survival (74.7 mo vs 25.6 mo) in patients with FLT3-mutant (D835 and I836) or FLT3-ITD (exon 14 insertions) acute myeloid leukemia compared to Cytosar-U (cytarabine) and Daunorubicin with placebo (PMID: 28644114). | detail... 28644114 detail... |
| FLT3 D835del | acute myeloid leukemia | sensitive | FLT3 Inhibitor | 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). | 31665578 detail... detail... |
| FLT3 D835del | hematologic cancer | sensitive | FLT3 Inhibitor | Gilteritinib | Preclinical | Actionable | In a preclinical study, Xospata (gilteritinib) treatment inhibited Flt3 signaling and viability in a cell line expressing FLT3 D835del in culture and inhibited growth in a transplant model (PMID: 40196870). | 40196870 |
| FLT3 D835del | hematologic cancer | decreased response | FLT3 Inhibitor | Quizartinib | Preclinical | Actionable | In a preclinical study, cells expressing FLT3 D835del were less sensitive to Vanflyta (quizartinib) compared to cells expressing a FLT3-ITD in culture and in a transplant model (PMID: 40196870). | 40196870 |
| FLT3 D835del | hematologic cancer | sensitive | FLT3 Inhibitor | Midostaurin | Preclinical - Cell culture | Actionable | In a preclinical study, Rydapt (midostaurin) treatment decreased viability in a cell line expressing FLT3 D835del in culture (PMID: 40196870). | 40196870 |