Balversa

(Erdafitinib)

ApprovedSmall molecule

Erdafitinib is used to treat a type of bladder cancer (urothelial carcinoma) that has a specific genetic mutation. It works by blocking proteins that help cancer cells grow and divide.[2] Balversa is currently approved and in use across 22 indications[4].[1]

Balversa is one of 516 small molecule programs targeting Urinary Bladder Carcinoma. It is currently in Approved.

Indications

Total Trials

Active Trials

515

Competitors

FDA Applications

NDA/BLA/ANDA regulatory filings

Patents

Pipeline

Status by Indication[4][1]

Indication

Urinary Bladder CarcinomaActive, not recruiting

Bladder TumorApproved

Hepatocellular CarcinomaApproved

Prostate AdenocarcinomaApproved

Ovarian CancerActive, not recruiting

Metastatic Prostate CancerApproved

LymphomaApproved

Liver DiseaseApproved

Prostate CarcinomaApproved

Urinary Bladder CancerApproved

Urinary Bladder CarcinomaApproved

Active, not recruiting

Bladder TumorApproved

Approved

Hepatocellular CarcinomaApproved

Approved

Prostate AdenocarcinomaApproved

Approved

Ovarian CancerPreclinical

Active, not recruiting

Metastatic Prostate CancerApproved

Approved

LymphomaApproved

Approved

Liver DiseaseApproved

Approved

Prostate CarcinomaApproved

Approved

Urinary Bladder CancerApproved

Approved

Showing 10 of 22 indications

Competition

Competitive Landscape

401 competitors in Lymphoma

#DrugCompanyPhaseTrials

Balversa

Johnson & Johnson

Approved

30 2

Zofran

Novartis

Preclinical

2 3

Cabenuva

GSK

Preclinical

1 4

Norvir

AbbVie

Preclinical

1 5

Emend

CCidara Therapeutics Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)

Preclinical

1 6

Kenalog

BBausch Health Americas, Inc.

Preclinical

1 7

Nuvigil

NNuvo Research GmbH

Preclinical

1 8

Elitek

AAzienda U.S.L. 1 di Massa e Carrara

Preclinical

—9

Decadron

QQuince Therapeutics S.p.A.

Preclinical

—10

Solu-Medrol

MMassachusetts Eye and Ear Infirmary

Preclinical

—

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2026

Phase 2Active, not recruiting

Recurrent Glioma

NCT05859334

Phase 1Active, not recruiting

Locally Advanced Bladder Urothelial Carcinoma

NCT04963153

Phase 2Active, not recruiting

Tic Disorder

NCT03210714

PreclinicalActive, not recruiting

Urothelial Carcinoma

NCT03473743

Phase 2Active, not recruiting

Advanced Lymphoma

NCT02465060

Phase 3Active, not recruiting

Urothelial Cancer

NCT03390504

Clinical

Trials by Indication[1]

Bladder Cancer4 trials

Drug Screening Using IMD in Bladder Cancer

Unknown status·—·Phase 1·NCT06204614·18 enrolled

A Study of Erdafitinib Versus Investigator Choice of Intravesical Chemotherapy in Participants Who Received Bacillus Calmette-Guérin (BCG) and Recurred With High Risk Non-Muscle-Invasive Bladder Cancer (NMIBC)

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04172675·107 enrolled

Testing Anti-Cancer Drugs Erdafitinib With or Without Atezolizumab in Patients With Localized Bladder Cancer Not Able to Receive Cisplatin Chemotherapy, NERA Trial

Withdrawn·NNational Cancer Institute (NCI)·Phase 2·NCT05564416

Show 1 more trial

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

Active, not recruiting·MMemorial Sloan Kettering Cancer Center·Phase 2·NCT04917809·20 enrolled

Adult2 trials

A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants

Completed· Johnson & Johnson Pharmaceutical Research & Development, L.L.C. logo

Johnson & Johnson Pharmaceutical Research & Development, L.L.C.·Phase 1·NCT04330248·15 enrolled

A Study to Evaluate the Effect of Fluconazole and Itraconazole on Erdafitinib Pharmacokinetics in Healthy Adult Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03135106·54 enrolled

Prostate Cancer2 trials

Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer

Terminated·UUniversity of Washington·Phase 2·NCT03999515·3 enrolled

Erdafitinib for the Treatment of Patients With Castration-Resistant Prostate Cancer

Terminated·MM.D. Anderson Cancer Center·Phase 2·NCT04754425·11 enrolled

Advanced Lymphoma2 trials

MATCH Treatment Subprotocol K1: Phase 2 Study of JNJ-42756493 (Erdafitinib) in Patients With Tumors With FGFR Amplifications

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06308822·35 enrolled

Molecular Analysis for Therapy Choice (MATCH)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT02465060·6,452 enrolled

Urothelial Cancer2 trials

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

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02365597·239 enrolled

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 recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 3·NCT03390504·629 enrolled

18 more indications

Trial1 trial

The Drug Rediscovery Protocol (DRUP Trial)

Recruiting·TThe Netherlands Cancer Institute·Phase 2·NCT02925234·1,550 enrolled

Advanced Solid Cancers1 trial

A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of JNJ-63723283, an Anti-Programmed Cell Death (PD)-1 Monoclonal Antibody, as Monotherapy or in Combination With Erdafitinib in Japanese Participants With Advanced Solid Cancers

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03547037·22 enrolled

Tics1 trial

A Study to Determine the Effect of Food on the Pharmacokinetics of Erdafitinib in Healthy Participants

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03066687·16 enrolled

Cancer1 trial

FGFR Inhibitor in FGFR Dysregulated Cancer

Terminated·LLung Cancer Group Cologne·Phase 2·NCT03827850·22 enrolled

Cholangiocarcinoma1 trial

A Study to Evaluate the Clinical Efficacy of JNJ-42756493 (Erdafitinib), A Pan-Fibroblast Growth Factor Receptor (FGFR) Tyrosine Kinase Inhibitor, In Asian Participants With Advanced Non-Small-Cell Lung Cancer, Urothelial Cancer, Esophageal Cancer Or Cholangiocarcinoma

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT02699606·35 enrolled

Ovarian Cancer1 trial

Erdafitinib in Metastatic Steroid-cell Ovarian Cancer

Completed·UUniversity Health Network, Toronto·N/A·NCT06328491·1 enrolled

Hepatic Impairment1 trial

A Study to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetics of Erdafitinib

Terminated· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT03587363·26 enrolled

Tic Disorder1 trial

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)

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03210714·20 enrolled

Growth1 trial

Expanded Access Program (EAP) for Participants With Advanced Cancers and Fibroblast Growth Factor Receptor (FGFR) Genetic Alterations Who Have Exhausted All Treatment Options

Approved for marketing· Johnson & Johnson logo

Johnson & Johnson··NCT03825484

Breast Cancer1 trial

Fulvestrant, Palbociclib and Erdafitinib in ER+/HER2-/FGFR-amplified Metastatic Breast Cancer

Completed·VVanderbilt-Ingram Cancer Center·Phase 1·NCT03238196·35 enrolled

Treatment1 trial

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

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT06351371·35 enrolled

Solid Tumor1 trial

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

Completed· Johnson & Johnson logo

Johnson & Johnson·Phase 2·NCT04083976·316 enrolled

Urothelial Carcinoma1 trial

A Phase 1b-2 Study to Evaluate Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Various Regimens of Erdafitinib in Subjects With Metastatic or Locally Advanced Urothelial Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT03473743·125 enrolled

Non-Muscle Invasive Bladder Neoplasms1 trial

Phase 1/2 Study of Erdafitinib Intravesical Delivery System (TAR-210) in Participants With Non-Muscle-Invasive or Muscle-Invasive Bladder Cancer

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Preclinical·NCT05316155·235 enrolled

Urinary Bladder Neoplasms1 trial

A Phase 1 Study to Evaluate the Tolerability, Safety, and Pharmacokinetics of TAR-210 in Japanese Participants With Bladder Cancer and Selected FGFR Mutations or Fusions

Active, not recruiting· Johnson & Johnson logo

Johnson & Johnson·Phase 1·NCT05567185·5 enrolled

Recurrent Glioma1 trial

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

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT05859334·30 enrolled

Locally Advanced Bladder Urothelial Carcinoma1 trial

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

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 1·NCT04963153·24 enrolled

Advanced Malignant Solid Neoplasm1 trial

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

Active, not recruiting·NNational Cancer Institute (NCI)·Phase 2·NCT03155620·1,377 enrolled

Regulatory

FDA Approval Timeline[5]

Apr 12, 2019

BALVERSA

NDA NDA212018

Apr 2, 2020

BALVERSA

NDA NDA212018

Apr 27, 2022

BALVERSA

NDA NDA212018

Apr 27, 2022

BALVERSA

NDA NDA212018

Jan 11, 2023

BALVERSA

NDA NDA212018

Mar 20, 2023

BALVERSA

NDA NDA212018

Jan 19, 2024

BALVERSA

NDA NDA212018

Jan 19, 2024

BALVERSA

NDA NDA212018

Jan 19, 2024

BALVERSA

NDA NDA212018

Oct 9, 2024

BALVERSA

NDA NDA212018

Oct 17, 2025

BALVERSA

NDA NDA212018

Sources

References

[1]
ClinicalTrials.gov — 30 trial records for Erdafitinib. U.S. National Library of Medicine, National Institutes of Health.
[2]
MedlinePlus Drug Information — Balversa drug information. U.S. National Library of Medicine, National Institutes of Health.
[3]
ChEMBL — Erdafitinib compound record. European Bioinformatics Institute (EMBL-EBI).
[4]
Open Targets Platform — Drug–disease associations for Erdafitinib. EMBL-EBI & Wellcome Sanger Institute.
[5]
OpenFDA — FDA approval records (NDA NDA212018). U.S. Food & Drug Administration.
[6]
FDA Orange Book — Patent and exclusivity data for Balversa. U.S. Food & Drug Administration.
[7]
PubMed — 1 publication indexed for Erdafitinib. U.S. National Library of Medicine.
[8]
SEC EDGAR — Johnson & Johnson company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Mechanism of Action: FGFR Inhibitor[3]
Modality: Small molecule[3]
Highest Phase: Approved[1]
Company: Johnson & Johnson

Patent Landscape[6]

Patent Cliff

Apr 28, 2031

Earliest patent expiration — generic entry possible after this date

Patent #Expires

9464071Apr 28, 2031

8895601Apr 12, 2033

9902714Mar 26, 2035

12037644Oct 18, 2035

10898482Feb 9, 2036

4 more patents

11684620Feb 9, 2036

12678498Jun 12, 2036

10478494Aug 13, 2036

11077106Feb 2, 2038

Key Publications[7]

Erdafitinib in FGFR-Altered Advanced Urothelial Carcinoma: THOR

N Engl J MedMay 4, 2023DOI: 10.1056/NEJMoa2308849

Balversa

Status by Indication[4][1]

Competitive Landscape

Expected Milestones

Q4 2026

Trials by Indication[1]

Bladder Cancer4 trials

Adult2 trials

Prostate Cancer2 trials

Advanced Lymphoma2 trials

Urothelial Cancer2 trials

Trial1 trial

Advanced Solid Cancers1 trial

Tics1 trial

Cancer1 trial

Cholangiocarcinoma1 trial

Ovarian Cancer1 trial

Hepatic Impairment1 trial

Tic Disorder1 trial

Growth1 trial

Breast Cancer1 trial

Treatment1 trial

Solid Tumor1 trial

Urothelial Carcinoma1 trial

Non-Muscle Invasive Bladder Neoplasms1 trial

Urinary Bladder Neoplasms1 trial

Recurrent Glioma1 trial

Locally Advanced Bladder Urothelial Carcinoma1 trial

Advanced Malignant Solid Neoplasm1 trial

FDA Approval Timeline[5]

References

Drug Info

Quick Facts

Patent Landscape[6]

Key Publications[7]

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