TAGRISSO (osimertinib)
TherapyAstraZeneca
TAGRISSO (osimertinib) from AstraZeneca is an EGFR inhibitor used across multiple EGFR-altered lung cancer settings.
Approvals
11
Indications
1
Biomarkers
1
Mapped tests
6
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and TAGRISSO. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where TAGRISSO is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Non-Small Cell Lung Cancer (NSCLC) Solid Tumor · Lung | EGFR (HER1)
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for TAGRISSO.
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 TAGRISSO for eligible patients.
Test
cobas EGFR Mutation Test v2
Roche Molecular Systems, Inc. (Roche Diagnostics)
Method
PCR
Specimen
Tissue (FFPE)
5 approvalsView test profile →
Test
FoundationOne CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Tissue (FFPE)
2 approvalsView test profile →
Test
FoundationOne Liquid CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Whole blood
1 approvalView test profile →
Test
Guardant360 CDx
Guardant Health, Inc.
Method
NGS
Specimen
Plasma
1 approvalView test profile →
Test
MI Cancer Seek (MCS)
Caris Life Sciences
Method
NGS
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
ONCO/Reveal Dx Lung & Colon Cancer Assay (O/RDx-LCCA)
Pillar Biosciences, Inc.
Method
NGS
Specimen
Tissue (FFPE)
1 approvalView test profile →