ORSERDU (elacestrant)
TherapyStemline Therapeutics
ORSERDU (elacestrant) from Stemline Therapeutics is an oral SERD used in ESR1-mutant hormone receptor–positive breast cancer.
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 ORSERDU. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where ORSERDU is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Breast Cancer Solid Tumor · Breast | ESR1
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for ORSERDU.
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 ORSERDU for eligible patients.
Test
Guardant360 CDx
Guardant Health, Inc.
Method
NGS
Specimen
Plasma
1 approvalView test profile →