Regulatory approval

Published by the Health Service Executive. Approved

As monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.

This is written in the approval document.

Reimbursement

CDS

Citation

Erdafitinib Monotherapy, 2025, version number 2, viewed 26/03/2026, https://healthservice.hse.ie/documents/6646/885_v2_Erdafitinib.pdf

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Therapeutic response

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

Organizations Biomarkers Cancer types Therapies
HSE (1) FGFR3 p.R248C Bladder Urothelial Carcinoma Erdafitinib
HSE (1) FGFR3 p.S249C Bladder Urothelial Carcinoma Erdafitinib
HSE (1) FGFR3 p.G370C Bladder Urothelial Carcinoma Erdafitinib
HSE (1) FGFR3 p.Y373C Bladder Urothelial Carcinoma Erdafitinib
HSE (1) FGFR3::TACC3 Bladder Urothelial Carcinoma Erdafitinib
HSE (1) FGFR3::BAIAP2L1 Bladder Urothelial Carcinoma Erdafitinib