Quizartinib

Quizartinib (Vanflyta, Daiichi Sankyo Europe GmbH) has 3 EU-approved indications in 1 tumour type. Each needs a biomarker result: FLT3 (3).
Approved indications of Quizartinib
Biomarker requirementRegimenSettingConditions
Acute myeloid leukaemia3
FLT3-ITD
+ standard cytarabine and anthracycline induction chemotherapy
Induction
Then maintenance monotherapy
FLT3-ITD
Monotherapy
Maint.
After quizartinib + standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy without progression
FLT3-ITD
+ standard cytarabine consolidation chemotherapy
Consol.
After quizartinib + standard cytarabine and anthracycline induction chemotherapy
Full text of section 4.1 (therapeutic indications)

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 leukaemia (AML) that is FLT3-ITD positive.

Label history

5 changes to the Vanflyta label since 2025, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes