NDAORALTABLETPriority Review
Approved
Apr 2019
Lifecycle
Peak
Competitive Pressure
0/100
Clinical Trials
16
Data completeness
7/8 — Comprehensive
Priority Review
BALVERSA (erdafitinib) by Johnson & Johnson is fibroblast growth factor receptor inhibitors [moa]. Approved for kinase inhibitor [epc]. First approved in 2019.
Drug data last refreshed 13h ago · AI intelligence enriched 1w ago
AI summarySynthesized from FDA + DailyMed + ClinicalTrials.gov data
BALVERSA (erdafitinib) is an oral, small-molecule fibroblast growth factor receptor (FGFR) inhibitor approved by the FDA in April 2019. It is indicated for patients with locally advanced or metastatic urothelial carcinoma harboring susceptible FGFR alterations. The drug works by selectively inhibiting FGFR signaling to halt tumor growth in FGFR-driven cancers.
$18MPart D
Peak11.6 years to LOEBALVERSA is in peak commercial phase with modest Part D spending (~$18M in 2023), suggesting a niche precision oncology position with specialized sales and medical affairs teams.
Mechanism of Action
Fibroblast Growth Factor Receptor Inhibitors
Pharmacologic Class:
Kinase Inhibitor
Indications
Indication data is being enriched from DailyMed and FDA labeling. Check back soon for approved therapeutic uses.
Clinical Trials (16)
Erdafitinib Monotherapy or in Combination With Cetrelimab in Muscle-invasive Bladder Cancer Patients With Fibroblast Growth Factor Receptor (FGFR ) Gene Alterations
Started Mar 2023
90 enrolled
Muscle-invasive Bladder Cancer
A Study of Erdafitinib Intravesical Delivery System in Japanese Participants With Bladder Cancer
Started Mar 2023
5 enrolled
Urinary Bladder NeoplasmsReceptors, Fibroblast Growth Factor
Study of Erdafitinib Intravesical Delivery System for Localized Bladder Cancer
Started Apr 2022
235 enrolled
Non-Muscle Invasive Bladder Neoplasms
Erdafitinib and Abiraterone Acetate or Enzalutamide in Treating Patients With Double Negative Prostate Cancer
Started Apr 2020
3 enrolled
Castration-Resistant Prostate CarcinomaDouble-Negative Prostate CarcinomaMetastatic Prostate Carcinoma+4 more
A Study of Steady-state Carbamazepine on the Single-dose of Erdafitinib Tablets in Healthy Adult Participants
Started Mar 2020
15 enrolled
Healthy
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Data Sources
- Drug label: DailyMed / FDA
- Clinical trials: ClinicalTrials.gov
- Patent data: FDA Orange Book
- Spending data: CMS Medicare
The information on this page is for informational purposes only and should not be used as a substitute for professional medical advice. Drug information is sourced from FDA, DailyMed, and other government databases. Adverse event data from FAERS does not establish causation. Always consult a healthcare professional for medical decisions.