Pemigatinib

Pemigatinib (Pemazyre, Incyte Biosciences Distribution B.V.) has 1 EU-approved indication in 1 tumour type. It needs a biomarker result: FGFR (1).
Approved indications of Pemigatinib
Biomarker requirementRegimenSettingConditions
Biliary tract cancer1
FGFR2 fusion
Monotherapy
2L
advanced
Cholangiocarcinoma only; After at least one prior line of systemic therapy
Full text of section 4.1 (therapeutic indications)

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.

Label history

7 changes to the Pemazyre label since 2022, none of them to the indications. Newest first, in the words of EMA's record of each procedure.

Changes