Gene
FGFR2
FGFR2 is a gene biomarker in the evidence tier "FDA companion diagnostic". This page lists evidence by type: FDA companion diagnostic assertions (1), Assay-provider ledger (44), Actionable biomarkers (11), and 8 more evidence types, each linked to its source.
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Rows recorded per section (log scale)
3 more sections with rows · 1 section measured, none recorded
FDA companion diagnostic
An FDA-cleared or approved companion diagnostic names this biomarker.
Evidence over time
Share of that year: what fraction of the trials and papers our biomarker dictionary matched in a year mention FGFR2. The denominator is documents that mention any gene, not every registered document, so improving the matcher moves both halves and never rewrites history. Gene named in free-text trial records. A mention, not a validated biomarker. Actionable-biomarker and target-disease-association evidence carries no date in our sources, so it is not on this chart. Publication mentions cover only papers cited by a registered clinical trial, not all of PubMed.
Trial mentions: plotted from 1990 to 2026, the years our matched corpus covers. Not plotted: 2 with no date at all.
Publication mentions: plotted from 1990 to 2023, the years our matched corpus covers. Not plotted: 22 at the structurally incomplete recent edge.
The yearly numbers
| Year | Trial mentions | Share of that year | Publication mentions | Share of that year |
|---|---|---|---|---|
| 2026 | 8 of 8,738 | 0.09% | not measured | |
| 2025 | 13 of 8,875 | 0.15% | not measured | |
| 2024 | 7 of 8,597 | 0.08% | not measured | |
| 2023 | 8 of 8,275 | 0.10% | 35 of 11,460 | 0.31% |
| 2022 | 12 of 8,285 | 0.14% | 31 of 13,598 | 0.23% |
| 2021 | 4 of 8,692 | 0.05% | 42 of 15,045 | 0.28% |
| 2020 | 13 of 7,640 | 0.17% | 45 of 14,459 | 0.31% |
| 2019 | 8 of 7,300 | 0.11% | 39 of 12,159 | 0.32% |
| 2018 | 4 of 6,927 | 0.06% | 24 of 11,854 | 0.20% |
| 2017 | 5 of 6,558 | 0.08% | 22 of 11,595 | 0.19% |
Showing 10 of 37 years.
FDA companion diagnostic assertions (1)
Shown in this order: most recent decision first.
| Diagnostic | Source biomarker wording | Manufacturer | Indication | Decision date |
|---|---|---|---|---|
| FoundationOne CDx | FGFR2 | Foundation Medicine, Inc. | Cholangiocarcinoma | 2020-04-17 |
Assay-provider ledger (44)
Shown in this order: most recent publication first.
| Company | Provider class | Validation | Papers | Most recent publication |
|---|---|---|---|---|
| Foundation Medicine | Diagnostic provider | Clinical validationAnalytical validation | 8 | August 01, 2026 +2 undated |
| Olympus Corporation of Americas | Reagent supplier | Clinical validationAnalytical validation | 1 | August 01, 2026 |
| THERMO FISHER SCIENTIFIC (Click-iT EdU kit, TaqMan Low-Density Array reagents, ExpressionSuite/DataAssist software) | Reagent supplier | Clinical validationAnalytical validation | 3 | August 01, 2026 |
| University of Pittsburgh Medical Center (UPMC) Molecular & Genomics Pathology (MGP) laboratory | Not a company | Clinical validationAnalytical validation | 1 | August 01, 2026 |
| Dxome Co. Ltd. | Diagnostic provider | Clinical validationAnalytical validation | 1 | March 01, 2026 |
Showing 5 of 44 assay-provider companies.
Actionable biomarkers (11)
Shown in this order: fixed catalogue order, not ranked.
| Alteration | Drug | Response | Disease | Source |
|---|---|---|---|---|
| FGFR2 fusion | Fgfr Inhibitors | response-associated | biliary tract neoplasm | Cancer Genome Interpreter |
| FGFR2 amplification | Fgfr Inhibitors | response-associated | breast adenocarcinoma | Cancer Genome Interpreter |
| FGFR2 (N549H,V564F,K659M,L617V,K641R,R565A) + FGFR2 fusion | Fgfr Inhibitors | responsive | cholangiocarcinoma | Cancer Genome Interpreter |
| FGFR2 fusion | Fgfr Inhibitors | response-associated | colorectal adenocarcinoma | Cancer Genome Interpreter |
| FGFR2 (M536I,M538I,I548V,N550,E566G,L618M,K660E) | Ponatinib | response-associated | endometrial carcinoma | Cancer Genome Interpreter |
Showing 5 of 11 actionable-biomarker assertions.
Trial mentions (104)
Shown in this order: fixed catalogue order, not by date.
| Trial | Source |
|---|---|
| NCT07775859 | Trial biospecimen (AACT) |
| NCT03656536 | Trial eligibility (AACT) |
| NCT04353375 | Trial eligibility (AACT) |
| NCT02109016 | Trial eligibility (AACT) |
| NCT06653777 | Trial eligibility (AACT) |
Showing 5 of 104 trial mentions.
Target-disease associations (1,499)
Shown in this order: fixed catalogue order, not ranked.
| Disease | Therapeutic area | Source |
|---|---|---|
| 14q24.1q24.3 microdeletion syndrome | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| 15q14 microdeletion syndrome | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| 15q24 microdeletion syndrome | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| 16p13.3 microduplication syndrome | genetic, familial or congenital disease | Mouse knockout (IMPC) |
| 17q11.2 microduplication syndrome | genetic, familial or congenital disease | Mouse knockout (IMPC) |
Showing 5 of 1,499 associations.
Vendor sourcing (306)
Shown in this order: alphabetical by organization.
| Organization | Role | Tier | Evidence | Citation |
|---|---|---|---|---|
| 3billion, Inc. (South Korea) | Testing lab / CRO (runs the assay) | Clinical-testing interpretation submitted (ClinVar)ClinVar clinical-testing submission | Same nucleotide change resulting in same amino acid change has been previously reported as pathogenic/likely pathogenic with strong evidence (ClinVar ID: VCV... | View ClinVar record SCV002012246.1 |
| ARUP Laboratories (United States) | Testing lab / CRO (runs the assay) | Clinical-testing interpretation submitted (ClinVar)ClinVar clinical-testing submission | The FGFR2 c.758C>G; p.Pro253Arg variant (rs77543610) is reported in the literature in several individuals with craniosynostosis disorders including reports o... | View ClinVar record SCV002048578.2 |
| Abbisko Therapeutics Co., Ltd. (China) | Trial sponsor | Named in trial inclusion criteriaTrial eligibility criteria | : * Patients must have a measurable target lesion (per RECIST v1.1) (not applicable to expansion cohort 1) where: * Dose Escalation: patients with histologi... | View trial NCT06632262 |
| Abbisko Therapeutics Co., Ltd. (China) | Trial sponsor | Named in trial inclusion criteriaTrial eligibility criteria | : 1. Patient should understand, sign, and date the written informed consent form prior to screening. 2. Male or female age 18 years or older. 3. For escalat... | View trial NCT05244551 |
| Abbisko Therapeutics Co., Ltd. (China) | Trial sponsor | Named in trial inclusion criteriaTrial eligibility criteria | : 1. Patients should understand, sign, and date the written informed consent form prior to screening 2. Male or female age 18 years or older 3. Patients wit... | View trial NCT05627063 |
Showing 5 of 306 sourcing records.
Trial-cited literature (426)
Shown in this order: newest first, then most cited.
| Publication | Journal | Year | Citations |
|---|---|---|---|
| Tinengotinib for adults with advanced or metastatic cholangiocarcinoma: a multicentre, open-label, phase 2 trial. | The lancet. Gastroenterology & hepatology | 2026 | 10 |
| Mechanisms of Clinical Resistance to Selective FGFR2 Inhibition by Lirafugratinib. | Annals of oncology : official journal of the European Society for Medical Oncology | 2026 | 3 |
| Concordance of ctDNA and tissue genomic profiling in advanced biliary tract cancer. | Journal of hepatology | 2025 | 40 |
| Prevalence of FGFR2b Protein Overexpression in Advanced Gastric Cancers During Prescreening for the Phase III FORTITUDE-101 Trial. | JCO precision oncology | 2025 | 24 |
| Acquired gene alterations in patients treated with ribociclib plus endocrine therapy or endocrine therapy alone using baseline and end-of-treatment circulating tumor DNA samples in the MONALEESA-2, -3, and -7 trials. | Annals of oncology : official journal of the European Society for Medical Oncology | 2025 | 16 |
Showing 5 of 426 papers.
Protein variant mentions (84)
Shown in this order: alphabetical by variant.
| Variant | Distinct papers | Year range | Sample papers |
|---|---|---|---|
| p.A172F | 1 | 2014 | PMID 24578066 |
| p.A314S | 1 | 2016 | PMID 27002187 |
| p.A344G | 2 | 2015 to 2016 | PMID 27002187, PMID 25741868 |
| p.A391E | 1 | 2018 | PMID 29280877 |
| p.A461V | 1 | 2022 | PMID 35945547 |
Showing 5 of 84 variants.
Human sample screening reference (9)
Shown in this order: alphabetical by variant.
| Variant | GDC project | Disease / site | Affected cases | Profiled cases | Observed frequency | 95% interval |
|---|---|---|---|---|---|---|
| p.D101Y | TCGA-UCEC | Not Reported; Epithelial Neoplasms, NOS; Adenomas and Adenocarcinomas; Cystic, Mucinous and Serous Neoplasms; Corpus uteri; Uterus, NOS | 1 | 559 | 0.18% | 0.03% to 1.01% |
| p.E163K | TCGA-SKCM | Nevi and Melanomas; Skin; Connective, subcutaneous and other soft tissues; Lymph nodes; Nasal cavity and middle ear; Vulva; Breast; Bones, joints and articular cartilage of other and unspecified sites; Retroperitoneum and peritoneum; Vagina; Colon; Adrenal gland; Corpus uteri; Other and ill-defined sites; Liver and intrahepatic bile ducts; Anus and anal canal; Spinal cord, cranial nerves, and other parts of central nervous system; Small intestine; Bronchus and lung; Brain; Parotid gland | 2 | 470 | 0.43% | 0.12% to 1.54% |
| p.F276C | TCGA-CHOL | Adenomas and Adenocarcinomas; Liver and intrahepatic bile ducts; Pancreas; Other and unspecified parts of biliary tract | 1 | 51 | 1.96% | 0.35% to 10.30% |
| p.K659M | CPTAC-3 | Not Applicable; Transitional Cell Papillomas and Carcinomas; Ductal and Lobular Neoplasms; Adenomas and Adenocarcinomas; Gliomas; Epithelial Neoplasms, NOS; Complex Epithelial Neoplasms; Complex Mixed and Stromal Neoplasms; Lipomatous Neoplasms; Squamous Cell Neoplasms; Myeloid Leukemias; Nevi and Melanomas; Stomach; Other and ill-defined sites in lip, oral cavity and pharynx; Unknown; Colon; Other and unspecified urinary organs; Floor of mouth; Other and unspecified parts of mouth; Gum; Bronchus and lung; Oropharynx; Other and unspecified parts of tongue; Base of tongue; Breast; Other and ill-defined sites; Larynx; Lip; Uterus, NOS; Hematopoietic and reticuloendothelial systems; Kidney; Brain; Skin; Pancreas; Tonsil | 1 | 1,815 | 0.06% | 0.01% to 0.31% |
| p.P253L | TCGA-COAD | Epithelial Neoplasms, NOS; Adenomas and Adenocarcinomas; Cystic, Mucinous and Serous Neoplasms; Complex Epithelial Neoplasms; Rectosigmoid junction; Colon | 1 | 461 | 0.22% | 0.04% to 1.22% |
Showing 5 of 9 cohort observations.
Literature-extracted relations (165)
Shown in this order: chemicals, then diseases.
| Related entity | Kind | Source relation label | Paper | Year |
|---|---|---|---|---|
| GEMCITABINE | Chemical | associate |
Locoregional gemcitabine plus surufatinib and camrelizumab in FGFR2-non-altered intrahepatic cholangiocarcinoma. | 2025 |
| SUNITINIB | Chemical | associate |
Genetic polymorphisms of <i>VEGFR2</i> and <i>FGFR2</i> genes are associated with exposure to sunitinib and cardiovascular toxicity. | 2025 |
| GEMCITABINE | Chemical | negative_correlate |
FIGHT-302: first-line pemigatinib vs gemcitabine plus cisplatin for advanced cholangiocarcinoma with <i>FGFR2</i> rearrangements. | 2020 |
| Genistein | Chemical | positive_correlate |
The effects of soy supplementation on gene expression in breast cancer: a randomized placebo-controlled study. | 2014 |
| CISPLATIN | Chemical | associate |
Inhibition of FGFR2 and FGFR1 increases cisplatin sensitivity in ovarian cancer. | 2010 |
Showing 5 of 165 relation assertions.
Organizations publishing (397)
Shown in this order: most papers first.
| Organization | Type | Papers | Years |
|---|---|---|---|
| Harvard Medical School | Academic | 26 | 2012 to 2026 |
| Dana-Farber Cancer Institute | Other | 23 | 2008 to 2024 |
| Memorial Sloan Kettering Cancer Center | Hospital | 21 | 2013 to 2024 |
| Mayo Clinic | Hospital | 20 | 2013 to 2024 |
| Government of the United States of America | Government | 17 | 1996 to 2023 |
Showing 5 of 397 organizations.
Where FGFR2 appears
- animal disease
- biological_process
- cancer or benign tumor
- cardiovascular disease
- disorder of ear
- disorder of visual system
- endocrine system disease
- gastrointestinal disease
- genetic, familial or congenital disease
- hematologic disease
- immune system disease
- infectious disease
- injury, poisoning or other complication
- integumentary system disease
- measurement
- medical procedure
- musculoskeletal or connective tissue disease
- nervous system disease
- nutritional or metabolic disease
- phenotype
- pregnancy or perinatal disease
- psychiatric disorder
- reproductive system or breast disease
- respiratory or thoracic disease
- urinary system disease
1,279 diseases touched.
Not on this page
Checked, with nothing recorded for this biomarker: fda biomarker qualification projects.