FGFR in urothelial carcinoma

1 EU-approved indication in urothelial carcinoma needs a FGFR result: erdafitinib (2nd line, advanced).

Line of therapy

Approved indications, Urothelial carcinoma
DrugBiomarker requirementRegimenSettingConditions
FGFR3 alteration1
Erdafitinib
Balversa
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

16 approvals for Urothelial need no biomarker and apply whatever the result. All approvals for Urothelial

See also

Label wording1

The sentence from section 4.1 of the SmPC that each indication above comes from.

  1. Erdafitinib (Balversa)
    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).