Regulatory approval

Published by the Health Canada. Approved

BALVERSA (erdafitinib) is indicated for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor (FGFR)3 genetic alterations, who have disease progression during or following at least one line of prior therapy including within 12 months of neoadjuvant or adjuvant therapy.

This is written in the approval document.

Citation

Janssen Inc. Balversa (erdafitinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00082880.PDF. Revised December 2025. Accessed April 2026.

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HC (1)	FGFR3 p.R248C	Bladder Urothelial Carcinoma	Erdafitinib
HC (1)	FGFR3 p.S249C	Bladder Urothelial Carcinoma	Erdafitinib
HC (1)	FGFR3 p.G370C	Bladder Urothelial Carcinoma	Erdafitinib
HC (1)	FGFR3 p.Y373C	Bladder Urothelial Carcinoma	Erdafitinib
HC (1)	FGFR3::TACC3	Bladder Urothelial Carcinoma	Erdafitinib