BALVERSA® (erdafitinib) for Healthcare Professionals
It’s time to take a different direction
THE FIRST AND ONLY treatment indicated specifically for locally advanced or metastatic urothelial carcinoma with susceptible fibroblast growth factor receptor (FGFR)3 or FGFR2 genetic alterations that has progressed after first-line platinum-based chemotherapy1
BALVERSA® is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma that has
susceptible fibroblast growth factor receptor (FGFR) 3 or FGFR2 genetic alterations and
progressed during or following at least one line of prior platinum-containing chemotherapy, including within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy.
Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA®.
Information on FDA-approved tests for the detection of FGFR genetic alterations in urothelial cancer is available at: http://www.fda.gov/CompanionDiagnostics.
This indication is approved under accelerated approval based on tumor response rate. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials.
FDA = U.S. Food and Drug Administration.
1. BALVERSA® [Prescribing Information]. Horsham, PA: Janssen Biotech, Inc.