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

health-canada-dpd

Clinical trials

Active trials (84)

Trials with an active ClinicalTrials.gov status, an intervention mapped to a derived drug and a condition mapped to an associated cancer. 36 recruiting · 24 active phase 3 · 445 in any status. Most recently updated first, 50 per page.

Computedrule biomarker-links-v1

clinicaltrialsPublishedShowing 1–50 of 84 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
NCT02465060	Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial)	active not recruiting	Phase 2

Literature

Linked publications (36)

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

pubmedPublishedShowing 1–25 of 36 publications · bibliographic data as recorded by PubMed; abstracts are not reproduced.

Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma.
· N Engl J Med · 2019 · PMID 31340094 · validated civic_curation pubmed
FGFR3 mutational status and protein expression in patients with bladder cancer in a Jordanian population.
· Cancer Epidemiol · 2010 · PMID 20542753 · 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.
· J Clin Oncol · 2017 · PMID 27870574 · validated civic_curation pubmed
Somatic FGFR3 Mutations Distinguish a Subgroup of Muscle-Invasive Bladder Cancers with Response to Neoadjuvant Chemotherapy.

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 Mutation3

Infigratinib

Bladder Carcinoma

Predictive

Supports Sensitivity Response

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

Supports Sensitivity Response

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

Supports Sensitivity Response

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

FGFR3 S249C5

Infigratinib + PD173074Substitutes

Lung Adenocarcinoma

Predictive

Supports Sensitivity Response

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

Supports Sensitivity Response

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

Supports Sensitivity Response

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

Supports Resistance

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

Supports Sensitivity Response

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

FGFR3 Amplification1
Pazopanib	Malignant Breast Neoplasm	Predictive	C	Does Not Support Sensitivity Response	3	accepted	EID7955 Patients with breast cancer had their tumor samples analyzed by Foundation Medicine in order to determine an appropriate clinical trial with targeted therapy or retrospectively to correlate with respo… (full text at CIViC) PMID 27489863 · Wheler et al., 2016 · Open in CIViC	civic

FGFR3 Amplification1

Pazopanib

Malignant Breast Neoplasm

Predictive

Does Not Support Sensitivity Response

accepted

EID7955

Patients with breast cancer had their tumor samples analyzed by Foundation Medicine in order to determine an appropriate clinical trial with targeted therapy or retrospectively to correlate with respo… (full text at CIViC)

PMID 27489863 · Wheler et al., 2016 · Open in CIViC

civic

FGFR3 N540K + TACC3 FusionTACC3 FGFR31
Erdafitinib + FutibatinibSubstitutes	Malignant NeoplasmALIAS	Predictive	D	Supports Resistance	3	accepted	EID12706 Ba/F3 cells expressing the FGFR3::TACC3 fusion with or without the N540K mutation were treated with multiple FGFR inhibitors, including erdafitinib and futibatinib. In parental Ba/F3 cells, the IC50 v… (full text at CIViC) PMID 37377403 · Facchinetti et al., 2023 · Open in CIViC	civic

FGFR3 N540K + TACC3 FusionTACC3 FGFR31

Erdafitinib + FutibatinibSubstitutes

Malignant NeoplasmALIAS

Predictive

Supports Resistance

accepted

EID12706

Ba/F3 cells expressing the FGFR3::TACC3 fusion with or without the N540K mutation were treated with multiple FGFR inhibitors, including erdafitinib and futibatinib. In parental Ba/F3 cells, the IC50 v… (full text at CIViC)

PMID 37377403 · Facchinetti et al., 2023 · Open in CIViC

civic

FGFR3 R248C1
R3Mab	Malignant NeoplasmALIAS	Predictive	D	Does Not Support Resistance	3	accepted	EID8321 In this preclinical study, R3Mab (a monoclonal antibody specific to FGFR3) inhibited ligand-independent proliferation in Ba/F3 cells expressing common bladder carcinoma variant: FGFR3 R248C. Authors n… (full text at CIViC) PMID 19381019 · Qing et al., 2009 · Open in CIViC	civic

FGFR3 R248C1

R3Mab

Malignant NeoplasmALIAS

Predictive

Does Not Support Resistance

accepted

EID8321

In this preclinical study, R3Mab (a monoclonal antibody specific to FGFR3) inhibited ligand-independent proliferation in Ba/F3 cells expressing common bladder carcinoma variant: FGFR3 R248C. Authors n… (full text at CIViC)

PMID 19381019 · Qing et al., 2009 · Open in CIViC

civic

FGFR3 G370C1
R3Mab	Malignant NeoplasmALIAS	Predictive	D	Does Not Support Resistance	3	accepted	EID10353 Ba/F3 cells transfected with wild type FGFR3 or common bladder carcinoma variant FGFR3 G372C both resulted in IL-3 independence with FGF1 dependence for growth. Monoclonal antibody R3Mab treatment wit… (full text at CIViC) PMID 19381019 · Qing et al., 2009 · Open in CIViC	civic

FGFR3 G370C1

R3Mab

Malignant NeoplasmALIAS

Predictive

Does Not Support Resistance

accepted

EID10353

Ba/F3 cells transfected with wild type FGFR3 or common bladder carcinoma variant FGFR3 G372C both resulted in IL-3 independence with FGF1 dependence for growth. Monoclonal antibody R3Mab treatment wit… (full text at CIViC)

PMID 19381019 · Qing et al., 2009 · Open in CIViC

civic

FGFR3 Y373C1
R3Mab	Malignant NeoplasmALIAS	Predictive	D	Does Not Support Resistance	3	accepted	EID10354 Pro-B Ba/F3 cells transfected with wild type FGFR3 resulted in IL-3 independence with FGF1 dependence for growth. Cell transfected FGFR3 with mutation Y375C also resulted in IL-3 independence and FGF1… (full text at CIViC) PMID 19381019 · Qing et al., 2009 · Open in CIViC	civic

FGFR3 Y373C1

R3Mab

Malignant NeoplasmALIAS

Predictive

Does Not Support Resistance

accepted

EID10354

Pro-B Ba/F3 cells transfected with wild type FGFR3 resulted in IL-3 independence with FGF1 dependence for growth. Cell transfected FGFR3 with mutation Y375C also resulted in IL-3 independence and FGF1… (full text at CIViC)

PMID 19381019 · Qing et al., 2009 · Open in CIViC

civic

FGFR3 K650E1
R3Mab	Malignant NeoplasmALIAS	Predictive	D	Does Not Support Resistance	3	accepted	EID10355 Ba/F3 cells transfected with wildtype FGFR3 resulted in IL-3 independence with FGF1 dependence for growth, whereas cells transfected with common bladder carcinoma variant FGFR3 K652E resulted in IL-3 … (full text at CIViC) PMID 19381019 · Qing et al., 2009 · Open in CIViC	civic

FGFR3 K650E1

R3Mab

Malignant NeoplasmALIAS

Predictive

Does Not Support Resistance

accepted

EID10355

Ba/F3 cells transfected with wildtype FGFR3 resulted in IL-3 independence with FGF1 dependence for growth, whereas cells transfected with common bladder carcinoma variant FGFR3 K652E resulted in IL-3 … (full text at CIViC)

PMID 19381019 · Qing et al., 2009 · Open in CIViC

civic

FGFR3 V555M1
AZ12908010 + Fexagratinib + PD173074Substitutes	Myeloid Neoplasm	Predictive	D	Supports Resistance	2	accepted	EID6408 Preclinical study of FGFR Inhibitors AZ12908010, PD173074 and AZD4547 in cancer cell lines. Cell lines with aberrant FGFR signalling were more sensitive to FGFR Inhibition. Sequencing of a myeloma cel… (full text at CIViC) PMID 22869148 · Chell et al., 2013 · Open in CIViC	civic

FGFR3 V555M1

AZ12908010 + Fexagratinib + PD173074Substitutes

Myeloid Neoplasm

Predictive

Supports Resistance

accepted

EID6408

Preclinical study of FGFR Inhibitors AZ12908010, PD173074 and AZD4547 in cancer cell lines. Cell lines with aberrant FGFR signalling were more sensitive to FGFR Inhibition. Sequencing of a myeloma cel… (full text at CIViC)

PMID 22869148 · Chell et al., 2013 · Open in CIViC

civic

FGFR3 N540K + FGFR3 S249C + PIK3CA E545KPIK3CA FGFR31
Erdafitinib	Urothelial Carcinoma	Predictive	C	Supports Resistance	4	accepted	EID12703 In this study of 21 patients with FGFR-driven urothelial carcinoma treated with selective FGFR inhibitors (including erdafitinib), post-progression molecular analyses (tissue and/or ctDNA sequencing) … (full text at CIViC) PMID 37377403 · Facchinetti et al., 2023 · Open in CIViC	civic

FGFR3 N540K + FGFR3 S249C + PIK3CA E545KPIK3CA FGFR31

Erdafitinib

Urothelial Carcinoma

Predictive

Supports Resistance

accepted

EID12703

In this study of 21 patients with FGFR-driven urothelial carcinoma treated with selective FGFR inhibitors (including erdafitinib), post-progression molecular analyses (tissue and/or ctDNA sequencing) … (full text at CIViC)

PMID 37377403 · Facchinetti et al., 2023 · Open in CIViC

civic

FGFR3 N540K + FGFR3 Y373C1
Erdafitinib + FutibatinibSequential	Urothelial Carcinoma	Predictive	C	Supports Resistance	4	accepted	EID12704 In this study of patients with FGFR-driven urothelial carcinoma treated with selective FGFR inhibitors, longitudinal ctDNA analysis identified emergent FGFR3 kinase domain mutations at disease progres… (full text at CIViC) PMID 37377403 · Facchinetti et al., 2023 · Open in CIViC	civic

FGFR3 N540K + FGFR3 Y373C1

Erdafitinib + FutibatinibSequential

Urothelial Carcinoma

Predictive

Supports Resistance

accepted

EID12704

In this study of patients with FGFR-driven urothelial carcinoma treated with selective FGFR inhibitors, longitudinal ctDNA analysis identified emergent FGFR3 kinase domain mutations at disease progres… (full text at CIViC)

PMID 37377403 · Facchinetti et al., 2023 · Open in CIViC

civic

Drug	Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
Gemcitabine	CA Health Canada	—	Marketed in Canada as GEMCITABINE INJECTION (DIN 02455382) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as GEMCITABINE FOR INJECTION USP (DIN 02409925) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as AJ-GEMCITABINE (DIN 02409062) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Nov 3, 2015	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as AJ-GEMCITABINE (DIN 02409054) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Nov 3, 2015	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02402858) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jan 12, 2022	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as AJ-GEMCITABINE (DIN 02409070) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Nov 3, 2015	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as GEMCITABINE FOR INJECTION, USP (DIN 02407299) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince May 8, 2017	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02402866) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jan 12, 2022	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as GEMCITABINE INJECTION (DIN 02555468) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 29, 2026	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as GEMCITABINE INJECTION (DIN 02565641) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02412071) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as GEMCITABINE FOR INJECTION USP (DIN 02409933) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as ACT GEMCITABINE (DIN 02436191) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Apr 27, 2020	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as ACT GEMCITABINE (DIN 02436205) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Apr 27, 2020	—	health-canada-dpd
Gemcitabine	CA Health Canada	—	Marketed in Canada as GEMCITABINE FOR INJECTION (DIN 02412101) under ATC L01BC05 GEMCITABINE. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approved	—	health-canada-dpd
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	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	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	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	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 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	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
Infigratinib	CA Health Canada	—	Marketed in Canada as TRUSELTIQ (DIN 02520664) under ATC L01EN03 INFIGRATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jan 23, 2023	—	health-canada-dpd
Infigratinib	CA Health Canada	—	Marketed in Canada as TRUSELTIQ (DIN 02520656) under ATC L01EN03 INFIGRATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jan 23, 2023	—	health-canada-dpd
Infigratinib	CA Health Canada	—	Marketed in Canada as TRUSELTIQ (DIN 02520648) under ATC L01EN03 INFIGRATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jan 23, 2023	—	health-canada-dpd
Infigratinib	CA Health Canada	—	Marketed in Canada as TRUSELTIQ (DIN 02520621) under ATC L01EN03 INFIGRATINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jan 23, 2023	—	health-canada-dpd
Pazopanib	CA Health Canada	—	Marketed in Canada as AURO-PAZOPANIB (DIN 02552957) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Jul 14, 2025	health-canada-dpd
Pazopanib	CA Health Canada	—	Marketed in Canada as PMS-PAZOPANIB (DIN 02525666) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 31, 2022	health-canada-dpd
Pazopanib	CA Health Canada	—	Marketed in Canada as VOTRIENT (DIN 02352303) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Aug 13, 2010	health-canada-dpd
Pazopanib	CA Health Canada	—	Marketed in Canada as VOTRIENT (DIN 02352311) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Jul 8, 2020	—	health-canada-dpd
Pazopanib	CA Health Canada	—	Marketed in Canada as SANDOZ PAZOPANIB (DIN 02521180) under ATC L01EX03 PAZOPANIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	withdrawnsource: Cancelled Pre Marketsince Oct 26, 2023	—	health-canada-dpd
Pazopanib	EU EMA	—	Renal-cell carcinoma (RCC) Votrient is indicated in adults for the first-line treatment of advanced renal-cell carcinoma (RCC) and for patients who have received prior cytokine therapy for advanced disease. Soft-tissue sarcoma (STS) Votrient is indicated for the treatment of adult patients with selective subtypes of advanced soft-tissue sarcoma (STS) who have received prior chemotherapy for metastatic disease or who have progressed within 12 months after (neo)adjuvant therapy. Efficacy and safety have only been established in certain STS histological tumour subtypes.	approved	Jun 14, 2010	ema
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

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