PharmaRadar360

PharmaRadar360

OncologyDrug intelligence

Balversa

Erdafitinib

FGFR kinase inhibitor. Developed by Johnson & Johnson. Clinical, regulatory, and source evidence are connected below.

Company
Johnson & Johnson
Target / MOA
FGFR1 路 FGFR2 路 FGFR3 路 FGFR4
Aliases
Balversa
Signals
21
Clinical trials
16
Approvals
0
Evidence sources
21

Latest signals

What changed

The three most recent source-backed changes linked to this drug.

clinical trialClinicalTrials.gov

Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)

Phase 2 路 ACTIVE_NOT_RECRUITING 路 National Cancer Institute (NCI)

clinical trialClinicalTrials.gov

Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2)

Phase 2 路 ACTIVE_NOT_RECRUITING 路 National Cancer Institute (NCI)

clinical trialClinicalTrials.gov

Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment

Phase 2 路 ACTIVE_NOT_RECRUITING 路 National Cancer Institute (NCI)

Approved uses

What regulators have approved

The indications section of each current US label, word for word, and the EU summary of each authorised product. Official sources as of Oct 21, 2026.

United States (FDA label)

Balversa 路 NDA212018 路 label version 14, effective Oct 24, 2025 路 DailyMed

Label section 1

1 INDICATIONS AND USAGE 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) ] . 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) ] .

European Union (EMA)

Balversa 路 EMEA/H/C/006050 路 Authorised, authorised Aug 22, 2024 (Commission decision C(2024) 6036) 路 EPAR

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).

EMA's summary; the full indication is in the product information on the EPAR page.

Regulatory history

Approvals over time

US original approvals and efficacy supplements (new indications, populations or dosing) from Drugs@FDA; EU authorisations and CHMP opinions on extensions. Official sources as of Oct 21, 2026.

United States

NDA212018 路 JANSSEN BIOTECH 路 first approved Apr 12, 2019

2 efficacy supplements approved

European Union

  • Balversa: Authorised since Aug 22, 2024

Patents and exclusivity

What FDA lists (US)

Patents and exclusivity as FDA lists them in the Orange Book (drugs) and the Purple Book (biologics), with approved generics and biosimilars. Expired listings are not shown. Official sources as of Oct 21, 2026.

NDA212018 (Orange Book)

9 listed patents, latest expiry Feb 2, 2038
  • US 9464071 路 expires Apr 28, 2031 路 U-3805
  • US 8895601 路 expires Apr 12, 2033 路 drug substance, drug product
  • US 9902714 路 expires Mar 26, 2035 路 drug product
  • US 12037644 路 expires Oct 18, 2035 路 U-3972
  • US 10898482 路 expires Feb 9, 2036 路 drug product, U-3066, U-3065, U-3067, U-2518, U-3805, U-3807, U-3806
  • US 11684620 路 expires Feb 9, 2036 路 U-3805, U-3807, U-3806
  • US 12678498 路 expires Jun 13, 2036 路 U-4584
  • US 10478494 路 expires Aug 13, 2036 路 U-3902
  • US 11077106 路 expires Feb 2, 2038 路 U-3196, U-3808

Exclusivity: I-930 until Jan 19, 2027 路 Orange Book entry

Generics and biosimilars

The Orange Book lists no approved generic (ANDA).

FDA's listings only: an approved generic or licensed biosimilar may not be on the market yet. Not a forecast of when they may launch, and not legal advice.

Safety

Boxed warnings and FDA safety communications

The boxed warning on each current US label, and FDA Drug Safety Communications that name the drug (FDA's list from January 2020). Official sources as of Oct 21, 2026.

Boxed warning

The current US label has no boxed warning.

FDA Drug Safety Communications

None on FDA's list names this drug.

Clinical trials

Key active studies

A focused view of recently updated studies 路 16 linked records.

Phase 2ACTIVE NOT RECRUITINGNCT03210714

Erdafitinib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With FGFR Mutations (A Pediatric MATCH Treatment Trial)

National Cancer Institute (NCI) 路 Updated Oct 16, 2026

Phase 2ACTIVE NOT RECRUITINGNCT06351371

Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2)

National Cancer Institute (NCI) 路 Updated Oct 15, 2026

Phase 2ACTIVE NOT RECRUITINGNCT05859334

Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment

National Cancer Institute (NCI) 路 Updated Oct 15, 2026

Phase 1ACTIVE NOT RECRUITINGNCT05316155

Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer

Janssen Research & Development, LLC 路 Updated Sep 25, 2026

Phase 2ACTIVE NOT RECRUITINGNCT02365597

An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer

Janssen Research & Development, LLC 路 Updated Sep 25, 2026

Phase 3ACTIVE NOT RECRUITINGNCT03390504

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

Janssen Research & Development, LLC 路 Updated Sep 25, 2026

Regulatory timeline

Approvals and agency activity

Verified regulatory records in reverse chronological order.

No regulatory event is available in this snapshot.

Related intelligence

Connected drugs

Records connected through the current intelligence graph.

DarzalexDaratumumab 路 Johnson & Johnson 路 OncologyTremfyaGuselkumab 路 Johnson & Johnson 路 ImmunologyStelaraUstekinumab 路 Johnson & Johnson 路 ImmunologyTecentriqAtezolizumab 路 Roche 路 OncologyTagrissoOsimertinib 路 AstraZeneca 路 OncologyRevlimidLenalidomide 路 Bristol Myers Squibb 路 OncologyPadcevEnfortumab Vedotin 路 Seagen 路 OncologyOpdivoNivolumab 路 Bristol Myers Squibb 路 Oncology

Source evidence

Where this profile comes from

Facts link back to original registries, regulators, labels, and publishers. Counts change as source records update.

ClinicalTrials.govofficial 路 Latest Oct 16, 202620
Professional referenceThis profile summarizes linked public evidence. It is not medical, legal, regulatory, or investment advice. Verify decisions against original sources.