Vanflyta (quizartinib) [product information]. EMA.

Regulatory approval published by the European Medicines Agency.

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.

Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication	Statements
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.	3

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type	Biomarker(s)	Cancer type	Therapy(ies)
Sensitivity (+)	FLT3-ITD	Acute Myeloid Leukemia	Quizartinib
Sensitivity (+)	FLT3-ITD	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Quizartinib
Sensitivity (+)	FLT3-ITD	Acute Myeloid Leukemia	Cytarabine, Idarubicin, Quizartinib