Regulatory approval

Published by the European Medicines Agency. Approved

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 indication is based on QuANTUM-First (NCT02668653), a randomized, double-blind, placebo-controlled trial of 539 patients where patients received cytarabine with either daunorubicin or idarubicin.

This is written in the approval document as:

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.

Citation

Daiichi Sankyo Europe GmbH. Vanflyta (quizartinib) [product information]. European Medicines Agency website. https://www.ema.europa.eu/en/documents/product-information/vanflyta-epar-product-information_en.pdf. Revised December 2024. Accessed October 20, 2025.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
EMA (1)	FLT3-ITD	Acute Myeloid Leukemia	Quizartinib
EMA (1)	FLT3-ITD	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Quizartinib
EMA (1)	FLT3-ITD	Acute Myeloid Leukemia	Cytarabine, Idarubicin, Quizartinib

Contributions

Date	Contributor	Description
2025-10-20	Van Allen lab	EMA approval for quizartinib
2023-11-06	European Medicines Agency	Indication received approval from the European Commission.