PEMAZYRE (pemigatinib)

TherapyIncyte

PEMAZYRE (pemigatinib) from Incyte is a targeted therapy used in FGFR-altered cholangiocarcinoma and other solid tumors.

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 PEMAZYRE. Select a testing pathway to see the eligible companion diagnostic tests.

Indication-specific approvals

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

Indication	Biomarker criteria	Notes
Cholangiocarcinoma Solid Tumor · Bile Duct	FGFR2 fusions and select rearrangements		View testing pathway →

Tumor-agnostic approvals

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

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 PEMAZYRE for eligible patients.

Test

FoundationOne CDx

Foundation Medicine, Inc.

Method

NGS

Specimen

Tissue (FFPE)

1 approvalView test profile →

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