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.

openfdaRegulatory3 approval records · authority, jurisdiction and indication text as published.

Jurisdiction · authority	Cancer	Indication	Status	Approval date	Source
US FDA	—	Efficacy supplement 2024-01-19 (see label)	approved	Jan 19, 2024	openfda
US FDA	—	Efficacy supplement 2024-01-19 (see label)	approved	Jan 19, 2024	openfda
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) ] .

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 18 hours 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 51–56 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
FGFR3 Y373C2
Erdafitinib	Urothelial 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
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	6,452	National Cancer Institute (NCI)NIH	3	Sep 29, 2026	clinicaltrials
NCT02365597	An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

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)