Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that FLT3-ITD status confers therapeutic sensitivity to Cytarabine, Idarubicin, Quizartinib in patients with Acute Myeloid Leukemia.
The European Medicines Agency (EMA) has authorized quizartinib in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by quizartinib single-agent maintenance therapy for the treatment of adult aptients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.
This statement is based on a regulatory approval from the European Medicines Agency:
VANFLYTA is indicated in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy, followed by VANFLYTA single-agent maintenance therapy for adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive.