PIQRAY (alpelisib)
TherapyNovartis
PIQRAY (alpelisib) from Novartis is a PI3K inhibitor used in PIK3CA-mutant hormone receptor–positive breast cancer.
Approvals
4
Indications
1
Biomarkers
1
Mapped tests
4
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and PIQRAY. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where PIQRAY is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Breast Cancer Solid Tumor · Breast | PIK3CA
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for PIQRAY.
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 PIQRAY for eligible patients.
Test
FoundationOne CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
FoundationOne Liquid CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Whole blood
1 approvalView test profile →
Test
MI Cancer Seek (MCS)
Caris Life Sciences
Method
NGS
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
therascreen PIK3CA RGQ PCR Kit
QIAGEN GmbH (Qiagen)
Method
PCR
Specimen
Tissue (FFPE)
1 approvalView test profile →