Erdafitinib

Erdafitinib (Balversa) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: FGFR (1).
Approved indications of Erdafitinib
Biomarker requirementRegimenSettingConditions
Urothelial carcinoma1
Susceptible FGFR3 genetic alterations
Monotherapy
2L
advanced
After at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting
Full text of section 4.1 (therapeutic indications)

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).

Label history

4 changes to the Balversa label since 2026, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes