XOSPATA (gilterinib)
TherapyAstellas Pharma
XOSPATA (gilterinib) from Astellas Pharma is a therapy used in relapsed or refractory FLT3-mutant 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 XOSPATA. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where XOSPATA 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 XOSPATA.
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 XOSPATA for eligible patients.
Test
LeukoStrat CDx FLT3 Mutation Assay
Invivoscribe Technologies, Inc.
Method
PCR
Specimen
Whole blood
1 approvalView test profile →