# Erdafitinib

Erdafitinib (Balversa) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: FGFR (1).

## Approved indications

### Urothelial carcinoma

| Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|
| Susceptible FGFR3 genetic alterations | Monotherapy | 2nd line, advanced | After at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting |

## Products

### Balversa

- Target: Pan-FGFR tyrosine kinase inhibitor
- Class: Fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitors
- ATC: L01EN01
- EU approval: 22 Aug 2024
- Label revised: 23 Jun 2026
- SmPC (EN): https://www.ema.europa.eu/en/documents/product-information/balversa-epar-product-information_en.pdf
- Fachinformation (DE): https://www.ema.europa.eu/de/documents/product-information/balversa-epar-product-information_de.pdf
- EPAR: https://www.ema.europa.eu/en/medicines/human/EPAR/balversa

Mechanism (SmPC section 5.1): Erdafitinib acts as a pan-fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor.

## Label wording

- **Erdafitinib** (Balversa), Urothelial carcinoma, 2nd line, advanced: “Balversa as monotherapy is indicated 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 (see section 5.1).” [SmPC](https://www.ema.europa.eu/en/documents/product-information/balversa-epar-product-information_en.pdf)

Source: section 4.1 of each summary of product characteristics (SmPC), EMA data as of 5 Nov 2026. AI models structured these entries and no person has checked them yet. oncolabels is a non-commercial reference for education and research and gives no medical advice; the current SmPC takes precedence.

Data under CC BY 4.0: credit oncolabels and the European Medicines Agency. Page: https://oncolabels.com/drugs/erdafitinib