Erdafitinib Monotherapy. NCCP National SACT Regimen. HSE.

Regulatory approval published by the Health Service Executive.

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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Regulatory approvals

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

Indication Statements
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. 6

Therapeutic response

Precision oncology relationships for therapeutic response derived from this document.

Organization(s) Biomarker(s) Cancer type Therapy(ies)
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