Regulatory approval

Published by the European Medicines Agency. Approved

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.

This is written in the approval document.

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.

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Therapeutic response

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

Organizations
Biomarkers
Cancer types
Therapies
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.