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Drug

Erdafitinib

Approved · EMA
ClassFibroblast growth factor receptor inhibitorEmerging researchLate-stage development

Also known as Balversa.

RxNorm2123125ChEMBLCHEMBL3545376ATCL01EN01UNII890E37NHMV
2
Research papers
14
Active clinical trials
4
Protein targets
1
Regulatory events
Latest activity
beta

Recent clinical, regulatory, research and industry developments relating to this drug.

A Phase 2 "Window of Opportunity" Trial of Targeted Therapy With Erdafitinib in Patients With Recurrent FGFR3-Altered Non-Muscle Invasive Bladder Cancer

Clinical trial2026-08-01Primary completion · ClinicalTrials.gov

Molecular Analysis for Therapy Choice (MATCH)

Clinical trial2026-07-31Results expected Q4 2026 · ClinicalTrials.gov

Phase Ib Trial of Erdafitinib Combined With Enfortumab Vedotin Following Prior Therapies for Metastatic Urothelial Carcinoma With FGFR2/3 Genetic Alterations

Clinical trial2026-07-31Results expected Q4 2026 · ClinicalTrials.gov

A Phase 2, Two-arm Multicenter, Open-Label Study to Determine the Efficacy and the Safety of Two Different Dose Regimens of a Pan-FGFR Tyrosine Kinase Inhibitor JNJ-42756493 in Subjects With Metastatic or Surgically Unresectable Urothelial Cancer With FGFR Genomic Alterations

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Clinical trial2026-07-06Results posted · ClinicalTrials.gov

A Phase 2, Open-label, Multi-centre, Multi-national Interventional Trial to Evaluate the Efficacy and Safety of Erdafitinib (ERDA) Monotherapy and Erdafitinib (ERDA) and Cetrelimab (CET) Combination as Neoadjuvant Treatment in Cisplatin-ineligible Patients With Muscle-invasive Bladder Cancer (MIBC) Whose Tumours Express Fibroblast Growth Factor Receptor ( FGFR ) Gene Alterations

Clinical trial2026-07-01Primary completion · ClinicalTrials.gov

A Phase 2 Study of Erdafitinib in Patients With Recurrent or Progressive IDH-Wild Type Glioma With an FGFR-TACC Gene Fusion

Clinical trial2026-06-17Results expected Q4 2026 · ClinicalTrials.gov

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) - Phase 2 Subprotocol of Erdafitinib in Patients With Tumors Harboring FGFR1/2/3/4 Alterations

Clinical trial2026-06-17Results posted · ClinicalTrials.gov

NCI-COG Pediatric MATCH (Molecular Analysis for Therapy Choice) Screening Protocol

Clinical trial2026-06-17Results posted · ClinicalTrials.gov

Approval: Balversa (EMA)

Regulatory2024-08-22EMA

Clinical and Genomic Landscape of FGFR3-Altered Urothelial Carcinoma and Treatment Outcomes with Erdafitinib: A Real-World Experience.

Research2023-11-01Clinical cancer research : an official journal of the American Association for Cancer Research

Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma.

Research2019-07-01The New England journal of medicine

Profile

Identifiers & mechanism

Canonical identifiers, marketed brand names and mechanism, resolved across RxNorm, ChEMBL and ATC.

Canonical name
Erdafitinib
Aliases & brands
Balversa
RxNorm CUI
2123125
ChEMBL ID
CHEMBL3545376
ATC codes
L01EN01
UNII
890E37NHMV
Primary mechanism
Fibroblast growth factor receptor inhibitor
Regulatory jurisdictions
ema

Pharmacology & targets

4 targets

Known molecular targets and mechanisms supported by curated pharmacology databases.

Fibroblast growth factor receptor 3
FGFR3 · P22607
INHIBITORFibroblast growth factor receptor inhibitor
Fibroblast growth factor receptor 1
FGFR1 · P11362
INHIBITORFibroblast growth factor receptor inhibitor
Fibroblast growth factor receptor 4
FGFR4 · P22455
INHIBITORFibroblast growth factor receptor inhibitor
Fibroblast growth factor receptor 2
FGFR2 · P21802
INHIBITORFibroblast growth factor receptor inhibitor

Regulatory timeline

1 event

The complete regulatory record, grouped by authority — approvals, safety advisories and label changes. Each authority shows its most recent events; expand one to read its full history.

Earliest approval
2024-08-22
Latest approval
2024-08-22
Authorities
EMA
Total events
1
emaEuropean Medicines Agency· 1 event
2024-08-22Approval
Approval: Balversa (EMA)
Indication: Balversa as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible FGFR3 genetic… Show full indication

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).

Evidence ↗

Contains information from the European Medicines Agency (European Medicines Agency), © EMA, reused under CC BY 4.0.

Clinical trials

28 trials

The current development programme across all trial phases — status mix, phase distribution and the late-stage studies shaping the evidence base.

Development programme
CLINICALTRIALS.GOV · LIVE REGISTRY
28
registered trials across all phases
LATEST COMPLETION 2026
14
Active studies
4
Recruiting
2
Late-stage (III+)
9
Completed
5
Discontinued
PHASE DISTRIBUTIONn = 28
Early Phase 11Phase 17Phase 1 / 21Phase 217Phase 31Phase N / A1

Late-stage studies

Phase III+ trials still open or recently active — where late-stage evidence is being generated.

A Phase 3 Study of Erdafitinib Compared With Vinflunine or Docetaxel or Pembrolizumab in Subjects With Advanced Urothelial Cancer and Selected FGFR Gene Aberrations

Active, not recruitingPH IIIJanssen Research & Development, LLCn=6292026

Recent completions

Trials that read out recently, adding to the completed evidence base.

A Phase 2 Study of Erdafitinib in Subjects With Advanced Solid Tumors and FGFR Gene Alterations

CompletedPH IIJanssen Research & Development, LLCn=3162026

A Randomized Phase 2 Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Subjects Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC) and FGFR Mutations or Fusions

CompletedPH IIJanssen Research & Development, LLCn=1072025

A Phase Ib Trial of Fulvestrant, Palbociclib (CDK4/6 Inhibitor) and Erdafitinib (JNJ- 42756493,Pan-FGFR Tyrosine Kinase Inhibitor) in ER+/HER2-/FGFR-Amplified Metastatic Breast Cancer (MBC)

CompletedPH IVanderbilt-Ingram Cancer Centern=352024

A Phase 2a Study to Evaluate The Clinical Efficacy of JNJ-42756493, A Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, In Asian Patients With Advanced Non-Small-Cell Lung Cancer, Urothelial Cancer, Gastric Cancer, Esophageal Cancer Or Cholangiocarcinoma

CompletedPH IIJanssen Research & Development, LLCn=352024

Erdafitinib in Metastatic Steroid-cell Tumor of the Ovary, NOS

CompletedN/AUniversity Health Network, Toronton=12022

A Phase 1/1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-PD-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Subjects With Advanced Solid Cancers

CompletedPH IJanssen Pharmaceutical K.K.n=222022

Research activity

2 papers

Key research shaping understanding of this drug, combining the latest publications with the most influential evidence.

Publications over time
20192023
Most influential

Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma.

The New England journal of medicine · 2019 · 1,006 cites

Clinical and Genomic Landscape of FGFR3-Altered Urothelial Carcinoma and Treatment Outcomes with Erdafitinib: A Real-World Experience.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2023 · 49 cites
Recent papers

Clinical and Genomic Landscape of FGFR3-Altered Urothelial Carcinoma and Treatment Outcomes with Erdafitinib: A Real-World Experience.

Clinical cancer research : an official journal of the American Association for Cancer Research · 2023 · 49 cites

Erdafitinib in Locally Advanced or Metastatic Urothelial Carcinoma.

The New England journal of medicine · 2019 · 1,006 cites
Major research themes3
Carcinoma, Transitional Cell1Cell-Free Nucleic Acids1Urinary Bladder Neoplasms1
Journals, researchers & institutions
Top journals
  • Clinical cancer research : an official journal of the American Association for Cancer Research1
  • The New England journal of medicine1
Leading researchers
  • Aggen DH1
  • Al-Ahmadie HA1
  • Avadhani A1
  • Bajorin DF1
  • Berger MF1
  • Bochner BH1
  • Brannon AR1
  • Burgess E1
Leading institutions
free-text, unnormalised
  • Columbia University Irving Medical Center1
  • Institute of Oncology1
  • Memorial Sloan Kettering Cancer Center1
  • Tel Aviv University1
  • Université Paris-Sud1
  • Weill Cornell Medical College1
References & data sources
  • RxNorm (U.S. National Library of Medicine) — drug identity
  • ChEMBL (EMBL-EBI) & UniProt — pharmacology and targets
  • Europe PMC — research literature
  • ClinicalTrials.gov — clinical trials
  • Regulatory event sources are credited in the Regulatory Timeline above.