VIZIMPRO (dacomitinib)
TherapyPfizer
VIZIMPRO (dacomitinib) from Pfizer is a targeted EGFR inhibitor used in select lung cancer settings.
Approvals
5
Indications
1
Biomarkers
1
Mapped tests
5
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and VIZIMPRO. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where VIZIMPRO 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 VIZIMPRO.
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 VIZIMPRO for eligible patients.
Test
FoundationOne CDx
Foundation Medicine, Inc.
Method
NGS
Specimen
Tissue (FFPE)
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 →
Test
therascreen EGFR RGQ PCR Kit
Qiagen Manchester, Ltd. (Qiagen)
Method
PCR
Specimen
Tissue (FFPE)
1 approvalView test profile →
Test
cobas EGFR Mutation Test v2
Roche Molecular Systems, Inc. (Roche Diagnostics)
Method
PCR
Specimen
Tissue (FFPE)
1 approvalView test profile →