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.

emaRegulatory1 approval record · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
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

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 minutes 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