Regulatory approval

Published by the Food and Drug Administration.

The U.S. Food and Drug Administration (FDA) 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. 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 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.

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.

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