BALVERSA® (erdafitinib) for Healthcare Professionals
It’s time to take a different direction with a targeted therapy
THE FIRST AND ONLY APPROVED SECOND-LINE (2L) ORAL TARGETED THERAPY
to treat locally advanced or metastatic urothelial carcinoma (mUC) expressing FGFR3
alterations/mutations that has progressed on or after at least one line of prior systemic therapy1
Limitations of Use
BALVERSA® is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy.
Indication
BALVERSA® (erdafitinib) is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy.
Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA®.
Information on FDA-approved tests for the detection of FGFR3 genetic alterations in urothelial cancer is available at: https://www.fda.gov/CompanionDiagnostics.
FDA = U.S. Food and Drug Administration; PD-L1/PD-1 = programmed death ligand 1/programmed cell death protein 1.
Reference
1. BALVERSA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.