FGFR
3 EU-approved indications of 3 drugs need a FGFR result, in 2 tumour types, most of them in biliary tract cancer and urothelial carcinoma.
Approved indications3
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| Biliary tract cancer2 | ||||
Lytgobiconditional | Monotherapy | 2L advanced | Cholangiocarcinoma only; Progressed after at least one prior line of systemic therapy | |
Pemazyreconditional | Monotherapy | 2L advanced | Cholangiocarcinoma only; After at least one prior line of systemic therapy | |
| Urothelial carcinoma1 | ||||
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 |
FGFR by tumour
Label wording3
The sentence from section 4.1 of the SmPC that each indication above comes from.
- 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).
- Pemigatinib (Pemazyre)
Pemazyre monotherapy is indicated for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.
- Futibatinib (Lytgobi)
Lytgobi monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement that have progressed after at least one prior line of systemic therapy.