Futibatinib

Futibatinib (Lytgobi, Taiho Pharma Netherlands B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: FGFR (1).
Approved indications of Futibatinib
Biomarker requirementRegimenSettingConditions
Biliary tract cancer1
FGFR2 fusion
Monotherapy
2L
advanced
Cholangiocarcinoma only; Progressed after at least one prior line of systemic therapy
Full text of section 4.1 (therapeutic indications)

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.

Label history

2 changes to the Lytgobi label since 2024, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes