FGFR3

Biomarker

FGFR3 alterations are commonly seen in urothelial and other cancers. These alterations may predict response to FGFR-targeted therapies.

Approvals
1
Indications
1
Therapies
1
Mapped tests
1

Where this biomarker is used

Each approval combines this biomarker with a specific indication and therapy. Select a therapy in the tables below to open its FDA-defined testing pathway.

Indication-specific approvals

Approvals where FGFR3 is defined directly in the indication labeling.

IndicationBiomarker criteriaTherapies
Urothelial Cancer
Solid Tumor · Bladder
  • Exon 7: R248C (c.742C>T), S249C (c.746C>G); exon 10: G370C (c.1108G>T) and Y373C (c.1118A>G); and fusions (FGFR3-TACC3v1 and FGFR3-TACC3v3)
Tumor-agnostic approvals

Approvals defined at the solid tumor level where FGFR3 is part of the eligibility criteria.

No tumor-agnostic approvals are currently mapped for this biomarker.

Tests that measure this biomarker

These assays report FGFR3 as part of their validated menu. In many cases they are identified in FDA labeling as acceptable companion diagnostics for specific approvals.

Test
therascreen FGFR RGQ RT-PCR Kit
Qiagen Manchester, Ltd.
Method
PCR
Specimen
Tissue (FFPE)

Reports FGFR3 as part of its biomarker panel.

This view is scoped to FGFR3. You can also see how it compares with other biomarkers and indications on the Know Your Companions™ map.