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BALVERSA (erdafitinib)

TherapyJohnson & Johnson

BALVERSA (erdafitinib) by Johnson & Johnson is a targeted therapy used in tumors harboring FGFR genetic alterations.

Approvals
1
Indications
1
Biomarkers
1
Mapped tests
1

Where this therapy is approved with a companion diagnostic

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

Indication-specific approvals

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

IndicationBiomarker criteriaNotes
Urothelial Cancer
Solid Tumor · Bladder
FGFR3
  • 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)
View testing pathway →
Tumor-agnostic approvals

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

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 BALVERSA for eligible patients.

Test
therascreen FGFR RGQ RT-PCR Kit
Qiagen Manchester, Ltd. (Qiagen)
Method
PCR
Specimen
Tissue (FFPE)
1 approvalView test profile →
This view is scoped to BALVERSA (erdafitinib). You can also see how it compares with other therapies and indications on the main Know Your Companions™ map.