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Molecular Profile FLT3 D835X
Therapy Cytarabine + Daunorubicin + Midostaurin
Indication/Tumor Type acute myeloid leukemia
Response Type 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 sensitive 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 (D835X and I836X) or FLT3-ITD (exon 14 insertions) acute myeloid leukemia compared to Cytosar-U (cytarabine) and Daunorubicin with placebo (PMID: 28644114). detail... 28644114 detail...
PubMed Id Reference Title Details
(28644114) Midostaurin plus Chemotherapy for Acute Myeloid Leukemia with a FLT3 Mutation. Full reference...
Full reference...
Rydapt (midostaurin) FDA Drug Label Full reference...