VANFLYTA (quizartinib)

TherapyDaiichi Sankyo

VANFLYTA (quizartinib) from Daiichi Sankyo is a FLT3-targeted therapy used in FLT3-ITD–positive AML.

Approvals

Indications

Biomarkers

Mapped tests

Where this therapy is approved with a companion diagnostic

Each row represents a defined combination of indication, biomarker criteria, and VANFLYTA. Select a testing pathway to see the eligible companion diagnostic tests.

Indication-specific approvals

Approvals where VANFLYTA is tied to a specific indication and biomarker definition.

Indication	Biomarker criteria	Notes
Acute Myeloid Leukemia (AML) Heme · Leukemia	FLT3 (ITD/TKD) ITD mutations and TKD mutations D835 and I836		View testing pathway →

Tumor-agnostic approvals

Approvals defined at the solid tumor level where biomarker criteria determine eligibility for VANFLYTA.

No tumor-agnostic companion diagnostic approvals are currently mapped for this therapy.

Tests used in these approvals

These assays are identified in FDA labeling or sponsor materials as companion diagnostics or acceptable tests when considering VANFLYTA for eligible patients.

Test

LeukoStrat CDx FLT3 Mutation Assay

Invivoscribe Technologies, Inc.

Method

PCR

Specimen

Whole blood

1 approvalView test profile →

This view is scoped to VANFLYTA (quizartinib). You can also see how it compares with other therapies and indications on the main Know Your Companions™ map.