VANFLYTA (quizartinib)
TherapyDaiichi Sankyo
VANFLYTA (quizartinib) from Daiichi Sankyo is a FLT3-targeted therapy used in FLT3-ITD–positive AML.
Approvals
1
Indications
1
Biomarkers
1
Mapped tests
1
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)
| 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 →