Biomarker · Gene alteration

FGFR2 fusion / rearrangement

FGFR2 gene fusions or rearrangements detected by sequencing or FISH; used as a predictive marker for FGFR inhibitors in cholangiocarcinoma.

CI-BIO-00000024FGFR2 graph →NCIt C150616

Also calledFGFR2 rearrangement · FGFR2-BICC1 · FGFR2 fusion-positive

Derived

Associated cancers (5)

Cancers mapped in ACCEPTED CIViC predictive, prognostic or diagnostic items whose variant (molecular markers) or gene (gene-level markers) is in this biomarker's scope. Counts by type and native level; each row links to the cancer's evidence tab.

Computedrule biomarker-links-v1

Cancer	Items	Predictive	Prognostic	Diagnostic	Levels A / B / C / D / E
Cholangiocarcinoma	3	3	—	—	1 / 1 / 1 / 0 / 0
Cholangiolocellular Small Duct Intrahepatic Cholangiocarcinoma	1	1	—	—	1 / 0 / 0 / 0 / 0
Intrahepatic Cholangiocarcinoma	1	1	—	—	0 / 1 / 0 / 0 / 0
Malignant Neoplasm	1	1	—	—	0 / 1 / 0 / 0 / 0

Derived

Drugs with predictive evidence (4)

Therapies named in in-scope PREDICTIVE CIViC items, plus targets of PREDICTS_RESPONSE_TO knowledge edges from in-scope variants. Sensitivity and resistance are counted separately and never merged into a verdict.

Computedrule biomarker-links-v1

Drug	CIViC items	Sensitivity	Resistance	Best level	Edges (S / R)	Cancer context
InfigratinibSmall Molecule	3	3	—	A	6 / 0	Cholangiocarcinoma
ErdafitinibSmall Molecule	2	2	—	A	3 / 0	Malignant Neoplasm, Transitional Cell Carcinoma

Curated evidence

Predictive evidence items (7)

ACCEPTED CIViC predictive items in scope, grouped by molecular profile and therapy with native level, direction and cancer context. 50 per page.

civicCuratedShowing 1–7 of 7 evidence items · levels, directions and significance as curated at the source; each row links to its CIViC record.

Therapy	Cancer	Type	Level	Direction · significance	Rating (1–5)	Status	Evidence	Source
FGFR2 Fusion + FGFR2 Fusion5
Infigratinib

Regulatory

Approvals mentioning the linked drugs (19)

Approval records of the derived drug set, plus records whose indication text names this biomarker. Each record names its authority, jurisdiction, indication text and status — a drug approved in one jurisdiction for one indication is not 'approved' in general, and an approval listed here is not necessarily restricted to this biomarker.

Computedrule biomarker-links-v1

ema

Clinical trials

Active trials (6)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 5 recruiting · 0 active phase 3 · 22 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–6 of 6 active studies · status and phase as posted by the registrant; each row links to the study record.

NCT	Title	Status	Phase	Enrollment (n)	Sponsor	Countries	Last update	Source
NCT06302621	Pemigatinib + Afatinib in Advanced Refractory Solid Tumors	recruiting	Phase 1	32	Massachusetts General Hospital

Literature

Linked publications (6)

Publications linked to the scope variant(s) through PubMed entity edges; 25 per page, newest first.

pubmedPublishedShowing 1–6 of 6 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Pemigatinib for previously treated, locally advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 study.
· Lancet Oncol · 2020 · PMID 32203698 · validated civic_curation pubmed
Infigratinib (BGJ398) in previously treated patients with advanced or metastatic cholangiocarcinoma with FGFR2 fusions or rearrangements: mature results from a multicentre, open-label, single-arm, phase 2 study.
· Lancet Gastroenterol Hepatol · 2021 · PMID 34358484 · validated civic_curation pubmed
Phase II Study of BGJ398 in Patients With FGFR-Altered Advanced Cholangiocarcinoma.
· J Clin Oncol · 2018 · PMID 29182496 · validated civic_curation pubmed
Evaluation of BGJ398, a Fibroblast Growth Factor Receptor 1-3 Kinase Inhibitor, in Patients With Advanced Solid Tumors Harboring Genetic Alterations in Fibroblast Growth Factor Receptors: Results of a Global Phase I, Dose-Escalation and Dose-Expansion Study.

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Erdafitinib	EU EMA	Urothelial Carcinoma	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).	approved	Aug 22, 2024	ema
Pemigatinib	EU EMA	Cholangiocarcinoma	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.conditional	approved	Mar 26, 2021	ema