Balversa (erdafitinib) [product monograph]. HC.

Regulatory approval published by the Health Canada.

Citation

Janssen Inc. Balversa (erdafitinib) [product monograph]. Health Canada website. https://pdf.hres.ca/dpd_pm/00077812.PDF. Revised November 2024. Accessed June 2025.

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Regulatory approvals

Approved indications from this document for cancer drugs containing at least one biomarker.

Indication Statements
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. 5

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Type Biomarker(s) Cancer type Therapy(ies)
Sensitivity (+) FGFR3 p.R248C Bladder Urothelial Carcinoma Erdafitinib
Sensitivity (+) FGFR3 p.S249C Bladder Urothelial Carcinoma Erdafitinib
Sensitivity (+) FGFR3 p.G370C Bladder Urothelial Carcinoma Erdafitinib
Sensitivity (+) FGFR3 p.Y373C Bladder Urothelial Carcinoma Erdafitinib
Sensitivity (+) FGFR3::TACC3 Bladder Urothelial Carcinoma Erdafitinib