biomarkersBiomarker

FGFR2 fusion or rearrangement

aka FGFR2 fusion, FGFR2 rearrangement, FGFR2-BICC1, FGFR2::BICC1, FGFR2 fusion-positive cholangiocarcinoma, FGFR2 alteration

FGFR2 fusions occur in 10 to 15 percent of intrahepatic bile duct cancers and almost nowhere else. Pemigatinib and futibatinib are approved for them after a first chemotherapy.

FGFR2 fusions (BICC1 is the commonest partner) and other rearrangements are detected by RNA or DNA sequencing or FISH. Pemigatinib (Pemazyre, 2020) is labelled for previously treated unresectable locally advanced or metastatic cholangiocarcinoma with an FGFR2 fusion or other rearrangement as detected by an FDA-approved test, FoundationOne CDx being the companion diagnostic; futibatinib (Lytgobi, 2022) for intrahepatic cholangiocarcinoma harbouring FGFR2 gene fusions or other rearrangements. Infigratinib's US approval was withdrawn in 2024. Acquired kinase-domain mutations (N550, V565F) drive resistance and are the target of next-generation FGFR2 inhibitors in trials.

Part ofFGFR2· FGFR2 All readouts

FGFR2: what it is and how drugs act on it · animated schematic, not to scale

Target · the protein and the cell it sits on
Drug · antibody, small molecule, cell or radioligand
Effect · signal, damage or kill

In plain words · FGFR2 is a growth receptor fused in bile-duct cancer and overproduced in gastric cancer.

Sequencing 2 approval thresholds

What it means for a patient

An FGFR2 fusion in bile duct cancer means pemigatinib or futibatinib, both tablets, are on label after first chemotherapy. They raise blood phosphate and can affect the eyes, so monitoring is part of treatment. Because the fusion is found in about one in eight intrahepatic cases, every patient with this cancer should have the tumour sequenced.

Written only from the label or guideline text cited on this page. Not medical advice; your own report and the reading your team gives it come first.

Scoring rule

An FGFR2 gene fusion or other rearrangement involving the kinase domain, by DNA or RNA sequencing or FISH.

“FGFR2 fusions and select rearrangements”
FDA: List of FDA-Authorized Companion Diagnostic Devices

Thresholds used in approvals

Threshold	Drug	Cancer	Regulator	Source
FGFR2 fusion or other rearrangement	Pemigatinib	Biliary tract cancer (cholangiocarcinoma)	FDA	label
FGFR2 gene fusion or other rearrangement	Futibatinib	Intrahepatic cholangiocarcinoma	FDA	label

Drugs whose label names it

Pemigatinib Futibatinib

Companion diagnostics (FDA list)

Device	Maker	Indication and sample	Drug	PMA / 510(k)
FoundationOne CDx	Foundation Medicine	Cholangiocarcinoma - Tissue	Pemigatinib	P170019/S013 (04/17/2020)

Tests that measure it

FoundationOne CDx Tempus xT and xT CDx FoundationOne CDx FoundationOne Liquid CDx Caris MI Profile Illumina TruSight Oncology Comprehensive

Trials that name this readout

Matched on the name and aliases of the readout in the title, setting and summary of each trial; a match is a mention, not proof the readout was an entry criterion.