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Molecular Profile FLT3 D835X
Therapy Cytarabine + Daunorubicin + Gilteritinib
Indication/Tumor Type acute myeloid leukemia
Response Type predicted - sensitive

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
FLT3 D835X acute myeloid leukemia predicted - sensitive Cytarabine + Daunorubicin + Gilteritinib Phase I Actionable In a Phase Ib trial, the addition of Xospata (gilteritinib) to induction and consolidation chemotherapy (cytarabine plus idarubicin or daunorubicin), followed by Xospata (gilteritinib) maintenance was well tolerated and resulted in a composite complete response rate of 89% (32/36) and a median overall survival of 46.1 mo in patients with acute myeloid leukemia harboring FLT3 mutations, including FLT3-ITD and/or D835 mutations (n=25 with FLT3-ITD, 5 with D835, and 10 with both) (PMID: 37379495; NCT02236013). 37379495
PubMed Id Reference Title Details
(37379495) Gilteritinib in Combination With Induction and Consolidation Chemotherapy and as Maintenance Therapy: A Phase IB Study in Patients With Newly Diagnosed AML. Full reference...