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Profile Name FLT3 I836del
Gene Variant Detail

FLT3 I836del (gain of function)

Relevant Treatment Approaches FLT3 Inhibitor

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
FLT3 I836del cancer sensitive FLT3 Inhibitor Tandutinib Preclinical - Cell culture Actionable In a preclinical study, Tandutinib (CT53518) inhibited phosphorylation of FLT3 and activation of ERK and STAT5, and reduced growth of transformed cells expressing FLT3 I836del in culture (PMID: 15256420). 15256420
FLT3 I836del cancer sensitive FLT3 Inhibitor Midostaurin Preclinical - Cell culture Actionable In a preclinical study, Rydapt (midostaurin) inhibited phosphorylation of FLT3, ERK, and STAT5, and growth of transformed cells expressing FLT3 I836del in culture (PMID: 17827387). 17827387
FLT3 I836del acute myeloid leukemia predicted - sensitive FLT3 Inhibitor Cytarabine + Mitoxantrone + Sorafenib Case Reports/Case Series Actionable In a clinical study, combination treatment with Cytosar-U (cytarabine), Novantrone (mitoxantrone), and Nexavar (sorafenib) treatment in an acute myeloid leukemia patient harboring FLT3 I836del led to remission with negative minimal residual disease (PMID: 33563661; NCT02670525). 33563661
FLT3 I836del acute myeloid leukemia predicted - sensitive FLT3 Inhibitor Azacitidine + Sorafenib + Venetoclax Case Reports/Case Series Actionable In a clinical study, combination treatment with Vidaza (azacitidine), Nexavar (sorafenib) and Venclexta (venetoclax) resulted in continued remission from Cytosar-U (cytarabine), Novantrone (mitoxantrone), and Nexavar (sorafenib) treatment in an acute myeloid leukemia patient harboring FLT3 I836del (PMID: 33563661; NCT02670525). 33563661
FLT3 I836del hematologic cancer sensitive FLT3 Inhibitor Gilteritinib Preclinical - Cell culture Actionable In a preclinical study, Xospata (gilteritinib) resulted in reduced cell viability in transformed cells expressing FLT3 I836del in culture (PMID: 32040554). 32040554
FLT3 I836del 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). 28644114 detail... detail...
FLT3 I836del 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). detail... 31665578 detail...