FGFR in biliary tract cancer
2 EU-approved indications in biliary tract cancer need a FGFR result: pemigatinib (2nd line, advanced) and futibatinib (2nd line, advanced).
Site
Line of therapy
| Drug | Biomarker requirement | Regimen | Setting | Conditions |
|---|---|---|---|---|
| FGFR2 fusion2 | ||||
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 | |
2 approvals for BTC need no biomarker and apply whatever the result. All approvals for BTC
See also
Label wording2
The sentence from section 4.1 of the SmPC that each indication above comes from.
- 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.