ROZLYTREK (entrectinib)
TherapyGenentech
ROZLYTREK (entrectinib) from Genentech is used in NTRK fusion–positive solid tumors and ROS1-positive lung cancer.
Approvals
4
Indications
2
Biomarkers
4
Mapped tests
2
Where this therapy is approved with a companion diagnostic
Each row represents a defined combination of indication, biomarker criteria, and ROZLYTREK. Select a testing pathway to see the eligible companion diagnostic tests.
Indication-specific approvals
Approvals where ROZLYTREK is tied to a specific indication and biomarker definition.
| Indication | Biomarker criteria | Notes | |
|---|---|---|---|
Non-Small Cell Lung Cancer (NSCLC) Solid Tumor · Lung | ROS1
| View testing pathway → |
Tumor-agnostic approvals
Approvals defined at the solid tumor level where biomarker criteria determine eligibility for ROZLYTREK.
| Level | Biomarker criteria | Notes | |
|---|---|---|---|
| Solid Tumors | NTRK1
|
Tests used in these approvals
These assays are identified in FDA labeling or sponsor materials as companion diagnostics or acceptable tests when considering ROZLYTREK for eligible patients.
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
2 approvalsView test profile →