Drug · Small Molecule

Erdafitinib

CI-DRUG-00000221Explore in graph →NCIt C103273 CHEMBL3545376 CIViC Approved

Regulatory

Approvals (8)

Each record names the authority, jurisdiction, indication text and status. A drug approved in one jurisdiction for one indication is not 'approved' in general.

health-canada-dpdRegulatory8 approval records from 3 sources (hover a row badge for its dataset) · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
CA Health Canada	—	Marketed in Canada as BALVERSA (DIN 02493225) under ATC L01EN01 ERDAFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 9, 2019	health-canada-dpd
CA Health Canada	—	Marketed in Canada as BALVERSA (DIN 02493233) under ATC L01EN01 ERDAFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 9, 2019	health-canada-dpd
CA Health Canada	—	Marketed in Canada as BALVERSA (DIN 02493217) under ATC L01EN01 ERDAFITINIB. Indications are not published in the Drug Product Database — see the Health Canada Product Monograph.	approvedsource: Marketed	Dec 9, 2019	health-canada-dpd

Health Canada records are DIN-level: one row per marketed product (brand, strength, form). The Drug Product Database does not publish indications, so no cancer is stated for these rows, and a cancelled or dormant DIN is the status of that one product — not a withdrawal of the molecule.

Data updated 2 days agoSource updated unknown

Derived

Development pipeline

Most advanced stage across all cancers, then per top-level cancer reached through trial conditions or approval indications. Approval in any ingested jurisdiction outranks trial phase; counts are interventional studies.

Scope	Stage	Max phase	Active	Recruiting	Phase 3	Trials	Approvals	Jurisdictions	First approval	First trial
All cancers	Approved	Phase 3	13	1	1	24	8	CA, EU, US	Apr 12, 2019	Apr 22, 2015
Malignant Bladder Neoplasm	Phase2	Phase 2	4	0	0	5	0	—	—	Aug 17, 2015
Non-Hodgkin Lymphoma	Phase2	Phase 2	4	0	0	5	0	—	—	Aug 17, 2015
Malignant Central Nervous System Neoplasm	Phase2	Phase 2	3	0	0	3

Curated evidence

Clinical evidence (56)

CIViC items in which this therapy appears, grouped by cancer context, then molecular profile. 50 items per page.

civicCuratedShowing 1–50 of 56 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 Fusion3
Erdafitinib	Bladder Carcinoma

Clinical trials

Trials with this intervention (26)

Most recently updated first, 50 per page.

clinicaltrialsPublishedShowing 1–26 of 26 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
NCT02365597	An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer	active not recruiting	Phase 2	239	Janssen Research & Development, LLCINDUSTRY	15	Sep 25, 2026	clinicaltrials
NCT03390504	A Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Participants With Advanced Urothelial Cancer and Selected Fibroblast Growth Factor Receptor (FGFR) Gene Aberrations

Molecule

Record

Kind: Small Molecule
Mechanism: Fibroblast growth factor receptor inhibitor
Targets: 4 genes
UNII: 890E37NHMV
Aliases: 1,2-Ethanediamine, N1-(3,5-dimethoxyphenyl)-N2-(1-methylethyl)-N1-(3-(1-methyl-1H-pyrazol-4-yl)-6-quinoxalinyl)-, Balversa, BALVERSA, Erdafitinib, JNJ 42756493, JNJ-42756493, JNJ42756493

Data updated 21 hours agoSource updated unknown

Identifiers

Codes (10)

Upstream identifiers kept as first-class codes; each links to its registry where a stable public URL exists.

System	Code	Label
ATC (WHO)	L01EN01	ERDAFITINIB
DIN (Health Canada)	02493217	BALVERSA
DIN (Health Canada)

FGFR3 Fusion4
Erdafitinib	Bladder Carcinoma	Predictive	A	Supports Sensitivity Response	4	submitted	EID11258 In this open-label, phase II trial, 99 patients with locally advanced and unresectable or metastatic urothelial carcinoma with various FGFR alterations who had a history of disease progression during … (full text at CIViC) PMID 31340094 · Loriot et al., 2019 · Open in CIViC	civic
〃	Bladder Urothelial Carcinoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID10405 Phase I dose-escalation cohort of patients with advanced solid tumors in which antineoplastic therapy (NCT01703481) was no longer effective using pan-FGFR inhibitor JNJ-42756493. Among 6 patients with… (full text at CIViC) PMID 31088831 · Bahleda et al., 2019 · Open in CIViC	civic
〃	Transitional Cell Carcinoma	Predictive	A	Supports Sensitivity Response	4	submitted	EID7262 Patients with metastatic or unresectable urothelial carcinoma havoring FGFR2 fusion, FGFR3 fusion or FGFR3 mutation were treated with pan-FGFR inhibitor, erdafitinib, in Phase 2 trial. 96 patients wer… (full text at CIViC) Open in CIViC	civic
〃	Transitional Cell Carcinoma	Predictive	A	Supports Sensitivity Response	3	submitted	EID7424 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

FGFR2 Fusion2
Erdafitinib	Bladder Urothelial Carcinoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID10404 Phase I dose-escalation cohort of patients with advanced solid tumors in which antineoplastic therapy (NCT01703481) was no longer effective using pan-FGFR inhibitor JNJ-42756493. Among 2 urothelial ca… (full text at CIViC) PMID 31088831 · Bahleda et al., 2019 · Open in CIViC	civic
〃	Cholangiocarcinoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID10406 Phase I dose-escalation cohort of patients with advanced solid tumors in which antineoplastic therapy (NCT01703481) was no longer effective, using pan-FGFR inhibitor erdafitinib (JNJ-42756493). Among … (full text at CIViC) PMID 31088831 · Bahleda et al., 2019 · Open in CIViC	civic

FGFR3 Mutation3
Erdafitinib	Bladder Urothelial Carcinoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID10397 Phase I dose-escalation cohort (NCT01703481) of patients with advanced solid tumors in which antineoplastic therapy was no longer effective using pan-FGFR inhibitor JNJ-42756493. All 16 patients with … (full text at CIViC) PMID 31088831 · Bahleda et al., 2019 · Open in CIViC	civic
〃	Transitional Cell Carcinoma	Predictive	A	Supports Sensitivity Response	4	rejected	EID7263 Patients with metastatic or unresectable urothelial carcinoma havoring FGFR2 fusion, FGFR3 fusion or FGFR3 mutation were treated with pan-FGFR inhibitor, erdafitinib, in Phase 2 trial. 96 patients wer… (full text at CIViC) Open in CIViC	civic
〃	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 S249C6
Erdafitinib	Bladder Urothelial Carcinoma	Predictive	C	Supports Sensitivity Response	2	submitted	EID12955 This report describes a patient with metastatic urothelial bladder cancer harboring an FGFR3 S249C mutation who developed disease progression after platinum-based chemotherapy and avelumab maintenance… (full text at CIViC) PMID 37343207 · Castro-Alonso et al., 2023 · Open in CIViC	civic
〃	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
Erdafitinib + QuisinostatCombination	Malignant Bladder NeoplasmALIAS	Predictive	D	Supports Sensitivity Response	2	submitted	EID12954 This preclinical study evaluated the combination of erdafitinib and quisinostat in bladder cancer models harboring FGFR3 alterations, including the FGFR3 S249C bladder cancer cell line UM-UC-14. Compa… (full text at CIViC) PMID 37479885 · Wang et al., 2023 · Open in CIViC	civic
Erdafitinib	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
〃	Transitional Cell Carcinoma	Predictive	A	Supports Sensitivity Response	4	submitted	EID7306 Patients with metastatic or unresectable urothelial carcinoma havoring FGFR2 fusion, FGFR3 fusion or FGFR3 mutation were treated with pan-FGFR inhibitor, erdafitinib, in Phase 2 trial. 96 patients wer… (full text at CIViC) Open in CIViC	civic
〃	Urothelial Carcinoma	Predictive	B	Supports Sensitivity Response	3	submitted	EID12953 In a retrospective cohort of 32 patients with metastatic urothelial carcinoma harboring FGFR2/3 alterations treated with erdafitinib, FGFR3 S249C was the most common alteration (19/32, 59%). The overa… (full text at CIViC) PMID 37682528 · Guercio et al., 2023 · Open in CIViC	civic

FGFR2 Mutation2
Erdafitinib	Cholangiocarcinoma	Predictive	C	Supports Sensitivity Response	3	submitted	EID10375 Phase I dose-escalation cohort (NCT01703481) of patients with advanced solid tumors in which antineoplastic therapy was no longer effective using pan-FGFR inhibitor erdafitinib (JNJ-42756493). 1 chola… (full text at CIViC) PMID 31088831 · Bahleda et al., 2019 · Open in CIViC	civic
〃	Cholangiocarcinoma	Predictive	C	Does Not Support Sensitivity Response	3	submitted	EID10398 Phase I dose-escalation cohort (NCT01703481) of patients with advanced solid tumors in which antineoplastic therapy was no longer effective using pan-FGFR inhibitor JNJ-42756493. 2 cholangiocarcinoma … (full text at CIViC) PMID 31088831 · Bahleda et al., 2019 · Open in CIViC	civic

TACC3 Fusion2
Erdafitinib	GlioblastomaCURATED_BROADER	Predictive	C	Supports Sensitivity Response	2	accepted	EID13165 In the phase II NCI-MATCH EAY131-K2 trial, two patients with WHO grade IV IDH1/2-wildtype glioblastoma harboring FGFR3 fusions experienced progression-free survival exceeding 168 days during erdafitin… (full text at CIViC) PMID 38603650 · Gong et al., 2024 · Open in CIViC	civic
〃	Malignant NeoplasmALIAS	Predictive	B	Supports Sensitivity Response	3	accepted	EID1919 Phase 1 study of pan-FGFR inhibitor JNJ-42756493 in patients with solid tumors. No responses were seen 36 patients without FGFR pathway aberrations. Among 23 patients with FGFR pathway aberrations, 5 … (full text at CIViC) PMID 26324363 · Tabernero et al., 2015 · Open in CIViC	civic

FGFR1 Amplification3
Erdafitinib	Malignant Breast Neoplasm	Predictive	B	Supports Sensitivity Response	2	accepted	EID12469 Fibroblast Growth Factor Receptor 1 (FGFR1) amplification is frequently observed in estrogen receptor-positive (ER+) breast cancer and is associated with poor prognosis and resistance to endocrine the… (full text at CIViC) PMID 38603651 · Gong et al., 2024 · Open in CIViC	civic
Erdafitinib + Fulvestrant + PalbociclibCombination	Malignant Breast Neoplasm	Predictive	B	Does Not Support Sensitivity Response	1	submitted	EID12485 Hormone-receptor positive HER2-negative (HR+) breast cancers can harbor alterations in fibroblast growth factor receptors (FGFRs), particularly FGFR1 amplification, which is associated with poor progn… (full text at CIViC) PMID 40627530 · Gonzalez-Ericsson et al., 2025 · Open in CIViC	civic
Erdafitinib	Malignant Lung Neoplasm	Predictive	D	Supports Sensitivity Response	2	submitted	EID7954 JNJ-42756493 (erdafitinib) inhibitory effect was tested across a broad panel of lung cancer cell lines. Increased inhibit was associated with FGFR1 amplification. However, not all FGFR1-amplified ce… (full text at CIViC) PMID 28341788 · Perera et al., 2017 · Open in CIViC	civic

BICC1 Fusion2
Erdafitinib	Malignant Endometrial NeoplasmCURATED_BROADER	Predictive	C	Supports Sensitivity Response	3	accepted	EID1920 Phase 1 study of pan-FGFR inhibitor JNJ-42756493 in patients with solid tumors. No responses were seen 36 patients without FGFR pathway aberrations. Among 23 patients with FGFR pathway aberrations, 4 … (full text at CIViC) PMID 26324363 · Tabernero et al., 2015 · Open in CIViC	civic
〃	Transitional Cell Carcinoma	Predictive	C	Supports Sensitivity Response	3	accepted	EID1917 Phase 1 study of pan-FGFR inhibitor JNJ-42756493 in patients with solid tumors. No responses were seen 36 patients without known FGFR pathway aberrations. Among 23 patients with FGFR pathway aberratio… (full text at CIViC) PMID 26324363 · Tabernero et al., 2015 · Open in CIViC	civic