Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FLT3-ITD status confers therapeutic sensitivity to Cytarabine, Daunorubicin, Midostaurin in patients with Acute Myeloid Leukemia.
The European Medicines Agency (EMA) has authorized midostaurin in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by midostaurin single agent maintence therapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are FLT3 mutation-positive. Midostaurin's product information further states that AML patients must have confirmation of the FLT3 mutation (internal tandem duplication [ITD] or tyrosine kinase domain [TKD]) using a validated test.
This statement is based on a regulatory approval from the European Medicines Agency:
Rydapt is indicated in combination with standard daunorubicin and cytarabine induction and high-dose cytarabine consolidation chemotherapy, and for patients in complete response followed by Rydapt single agent maintenance therapy, for adult patients with newly diagnosed acute myeloid leukaemia (AML) who are FLT3 mutation-positive.