Biomarker · Gene alteration

FGFR3 alteration (mutation or fusion)

Activating FGFR3 point mutations or fusions detected by sequencing of tumor tissue; used as a predictive marker for FGFR inhibitors in urothelial carcinoma.

CI-BIO-00000025FGFR3 graph →NCIt C150618

Also calledFGFR3 mutation · FGFR3 fusion · FGFR3-TACC3 · S249C

Derived

Associated cancers (9)

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
Malignant Neoplasm	6	6	—	—	0 / 0 / 0 / 6 / 0
Bladder Carcinoma	3	2	—	1	0 / 2 / 0 / 1 / 0
Transitional Cell Carcinoma	3	3	—	—	1 / 0 / 1 / 1 / 0
Malignant Bladder Neoplasm	2	2	—	—	0 / 1 / 0 / 1 / 0
Urothelial Carcinoma

Derived

Drugs with predictive evidence (12)

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
ErdafitinibSmall Molecule	6	3	3	A	3 / 5	Malignant Bladder Neoplasm, Malignant Neoplasm, Malignant Ovarian Brenner Tumor, Transitional Cell Carcinoma +1
R3Mab	5	1	4

Curated evidence

Predictive evidence items (19)

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

civicCuratedShowing 1–19 of 19 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
FGFR3 Overexpression2
Dovitinib +

Regulatory

Approvals mentioning the linked drugs (94)

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

FGFR3 Mutation3
Infigratinib	Bladder Carcinoma	Predictive	B	Supports Sensitivity Response	3	accepted	EID1910 Phase 1 study evaluated 132 patients who had advanced cancer with FGFR-aberrations treated with FGFR-inhibitor BGJ398. In the subgroup of eight patients with FGFR3-mutated bladder/urothelial cancer tr… (full text at CIViC) PMID 27870574 · Nogova et al., 2017 · Open in CIViC	civic
Cisplatin + GemcitabineCombination	Malignant Bladder NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	3	accepted	EID7566 In this study, 52 patients with Muscle Invasive Bladder Cancer (MIBC) were randomly selected and administered neoadjuvant cisplatin and gemcitabine chemotherapy. 39 out of 52 patients showed pathologi… (full text at CIViC) PMID 29941343 · Yang et al., 2018 · Open in CIViC	civic
Erdafitinib	Transitional Cell Carcinoma	Predictive	A	Supports Sensitivity Response	4	accepted	EID7422 In a phase 2 trial, patients with locally advanced and unresectable or metastatic urothelial carcinoma harboring FGFR3 mutation or FGFR2/3 fusion were treated with Erdafitinib. All the patients had a … (full text at CIViC) PMID 31340094 · Loriot et al., 2019 · Open in CIViC	civic

FGFR3 S249C5
Infigratinib + PD173074Substitutes	Lung Adenocarcinoma	Predictive	D	Supports Sensitivity Response	4	accepted	EID4871 In this study, 363 lung adenocarcinoma tumors of Indian origin were analyzed using targeted next-generation sequencing and mass spectrometry genotyping, and FGFR3 mutations were identified in 20 tumor… (full text at CIViC) PMID 27998968 · Chandrani et al., 2017 · Open in CIViC	civic
Erdafitinib	Malignant Bladder NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	3	accepted	EID8811 The 97-7 bladder cancer cell line is heterozygous for FGFR3 S249C, which formed stable homodimers and was constitutively phosphorylated unlike WT FGFR3 found in NHUC cells. Retrovirus-mediated deliver… (full text at CIViC) PMID 17384684 · Tomlinson et al., 2007 · Open in CIViC	civic
〃	Malignant Ovarian Brenner Tumor	Predictive	C	Supports Sensitivity Response	3	accepted	EID13162 In the phase II NCI-MATCH EAY131-K2 trial, a patient with malignant Brenner tumor of the ovary harboring an FGFR3 S249C (p.Ser249Cys) mutation achieved a partial response to erdafitinib, with a 73.9% … (full text at CIViC) PMID 38603650 · Gong et al., 2024 · Open in CIViC	civic
Cisplatin	Transitional Cell Carcinoma	Predictive	D	Supports Resistance	3	accepted	EID8642 Bladder cancer cell line 97-7 expressing endogenous FGFR3 S249C (IC50 44.6ug/ml) was resistant to cisplatin compared to two FGFR3 wild-type cell lines, 5637 (IC50 2.07ug/ml) and T24 (IC50 1.58ug/ml) a… (full text at CIViC) PMID 31316618 · Xie et al., 2019 · Open in CIViC	civic
Pazopanib	Transitional Cell Carcinoma	Predictive	C	Supports Sensitivity Response	2	accepted	EID1603 Case report of a 67 year old woman with high-grade papillary urothelial carcinoma. The patient underwent chemotherapy and palliative cystectomy followed by tumor progression and pulmonary lesion enlar… (full text at CIViC) PMID 25766722 · Palma et al., 2015 · Open in CIViC	civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Cisplatin	US FDA	—	Efficacy supplement 1993-04-22 (see label)	approved	Apr 22, 1993	openfda
Cisplatin	US FDA	—	Efficacy supplement 1981-12-29 (see label)	approved	Dec 29, 1981	openfda
Cisplatin	US FDA	Malignant Bladder Neoplasm	INDICATIONS Cisplatin Injection is indicated as therapy to be employed as follows: Metastatic Testicular Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic testicular tumors who have already received appropriate surgical and/or radiotherapeutic procedures. Metastatic Ovarian Tumors In established combination therapy with other approved chemotherapeutic agents in patients with metastatic ovarian tumors who have already received appropriate surgical and/or radiotherapeutic procedures. An established combination consists of Cisplatin Injection and cyclophosphamide. Cisplatin Injection, as a single agent, is indicated as secondary therapy in patients with metastatic ovarian tumors refractory to standard chemotherapy who have not previously received Cisplatin Injection therapy. Advanced Bladder Cancer Cisplatin Injection is indicated as a single agent for patients with transitional cell bladder cancer which is no longer amenable to local treatments, such as surgery and/or radiotherapy.	approved	Dec 19, 1978	openfda
Erdafitinib	US FDA	—	Efficacy supplement 2024-01-19 (see label)	approved	Jan 19, 2024	openfda
Erdafitinib	US FDA	—	Efficacy supplement 2024-01-19 (see label)	approved	Jan 19, 2024	openfda
Erdafitinib	US FDA	Urothelial Carcinoma	BALVERSA is indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA [see Dosage and Administration (2.1) and Clinical Studies (14.1) ] . BALVERSA is a kinase inhibitor indicated for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations whose disease has progressed on or after at least one line of prior systemic therapy. Select patients for therapy based on an FDA-approved companion diagnostic for BALVERSA. ( 1 , 2.1 ) Limitations of Use BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. ( 1 , 14.1 ) Limitations of Use BALVERSA is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy [see Clinical Studies (14.1) ] .	approved	Apr 12, 2019	openfda
Futibatinib	US FDA	Intrahepatic Cholangiocarcinoma	LYTGOBI is indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements [see Dosage and Administration (2.1) ] . This indication is approved under accelerated approval based on overall response rate and duration of response [see Clinical Studies (14.1) ] . Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). LYTGOBI is a kinase inhibitor indicated for the treatment of adult patients with previously treated, unresectable, locally advanced or metastatic intrahepatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other rearrangements. ( 1 , 2.1 ) This indication is approved under accelerated approval based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). ( 1 )accelerated	approved	Sep 30, 2022	openfda
Gemcitabine	US FDA	Non-Muscle Invasive Bladder Carcinoma	INLEXZO is indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS), with or without papillary tumors. INLEXZO is a nucleoside metabolic inhibitor-containing intravesical system, indicated for the treatment of adult patients with Bacillus Calmette-Guérin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors. ( 1 )	approved	Sep 9, 2025	openfda
Gemcitabine	US FDA	Malignant Ovarian Neoplasm	in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.	approved	Jun 27, 2025	openfda
Gemcitabine	US FDA	Malignant Pancreatic Neoplasm	as a single agent for the treatment of pancreatic cancer.	approved	Jun 27, 2025	openfda
Gemcitabine	US FDA	Lung Non-Small Cell Carcinoma	in combination with cisplatin, for the treatment of non-small cell lung cancer.	approved	Jun 27, 2025	openfda
Gemcitabine	US FDA	Malignant Breast Neoplasm	in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.	approved	Jun 27, 2025	openfda
Gemcitabine	US FDA	Malignant Ovarian Neoplasm	in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.	approved	Aug 3, 2017	openfda
Gemcitabine	US FDA	Lung Non-Small Cell Carcinoma	in combination with cisplatin for the treatment of non-small cell lung cancer.	approved	Aug 3, 2017	openfda
Gemcitabine	US FDA	Malignant Pancreatic Neoplasm	as a single agent for the treatment of pancreatic cancer.	approved	Aug 3, 2017	openfda
Gemcitabine	US FDA	Malignant Breast Neoplasm	in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.	approved	Aug 3, 2017	openfda
Gemcitabine	US FDA	Lung Non-Small Cell Carcinoma	in combination with cisplatin for the treatment of non-small cell lung cancer.	approved	Aug 4, 2011	openfda
Gemcitabine	US FDA	Malignant Pancreatic Neoplasm	as a single agent for the treatment of pancreatic cancer.	approved	Aug 4, 2011	openfda
Gemcitabine	US FDA	Malignant Breast Neoplasm	in combination with paclitaxel, for first-line treatment of metastatic breast cancer after failure of prior anthracycline-containing adjuvant chemotherapy, unless anthracyclines were clinically contraindicated.	approved	Aug 4, 2011	openfda
Gemcitabine	US FDA	Malignant Ovarian Neoplasm	in combination with carboplatin, for the treatment of advanced ovarian cancer that has relapsed at least 6 months after completion of platinum-based therapy.	approved	Aug 4, 2011	openfda
Pazopanib	US FDA	—	Efficacy supplement 2014-11-18 (see label)	approved	Nov 18, 2014	openfda
Pazopanib	US FDA	—	Efficacy supplement 2012-04-26 (see label)	approved	Apr 26, 2012	openfda
Pazopanib	US FDA	—	Efficacy supplement 2012-01-12 (see label)	approved	Jan 12, 2012	openfda
Pazopanib	US FDA	Renal Cell Carcinoma	advanced renal cell carcinoma (RCC).	approved	Oct 19, 2009	openfda
Pazopanib	US FDA	Soft Tissue Sarcoma	Limitations of Use : The efficacy of VOTRIENT for the treatment of patients with adipocytic soft tissue sarcoma or gastrointestinal stromal tumors has not been demonstrated.	approved	Oct 19, 2009	openfda
Pazopanib	US FDA	Soft Tissue Sarcoma	advanced soft tissue sarcoma (STS) who have received prior chemotherapy.	approved	Oct 19, 2009	openfda

Associated cancers (9)

Drugs with predictive evidence (12)

Predictive evidence items (19)

Approvals mentioning the linked drugs (94)

Active trials (84)

Linked publications (36)