Regulatory approval

Published by the Food and Drug Administration. Approved

VANFLYTA is a kinase inhibitor indicated in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.

This is written in the approval document.

Citation

Daiichi Sankyo, Inc. Itovebi (inavolisib) [package insert]. U.S. Food and Drug Administration website. https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/216993s001lbl.pdf. Revised June 2024. Accessed October 3, 2025.

Therapeutic response

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

Organizations	Biomarkers	Cancer types	Therapies
FDA (2)	FLT3-ITD	Acute Myeloid Leukemia	Quizartinib
FDA (2)	FLT3-ITD	Acute Myeloid Leukemia	Cytarabine, Daunorubicin, Quizartinib
FDA (2)	FLT3-ITD	Acute Myeloid Leukemia	Cytarabine, Idarubicin, Quizartinib

Contributions

Date	Contributor	Description
2025-10-03	Van Allen lab	On 2023-07-20 the FDA granted granted approval to quizartinib in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as a maintenance monotherapy following consolidation chemotherapy, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3 internal tandem duplication (ITD)-positive as detected by an FDA-approved test.
2023-07-20	Food and Drug Administration	Indication received traditional approval.