ENSACOVE (ensartinib)

TherapyXcovery Holdings, Inc.

ENSACOVE (ensartinib) from Xcovery Holdings is a targeted therapy for tumors with ALK pathway alterations.

Approvals

Indications

Biomarkers

Mapped tests

Where this therapy is approved with a companion diagnostic

Each row represents a defined combination of indication, biomarker criteria, and ENSACOVE. Select a testing pathway to see the eligible companion diagnostic tests.

Indication-specific approvals

Approvals where ENSACOVE is tied to a specific indication and biomarker definition.

Indication	Biomarker criteria	Notes
Non-Small Cell Lung Cancer (NSCLC) Solid Tumor · Lung	ALK gene rearrangements		View testing pathway →

Tumor-agnostic approvals

Approvals defined at the solid tumor level where biomarker criteria determine eligibility for ENSACOVE.

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 ENSACOVE for eligible patients.

Test

Vysis ALK Break Apart FISH Probe Kit

Abbott Molecular, Inc.

Method

FISH

Specimen

Tissue (FFPE)

1 approvalView test profile →

This view is scoped to ENSACOVE (ensartinib). You can also see how it compares with other therapies and indications on the main Know Your Companions™ map.