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Balversa (ERDAFITINIB)
Balversa works by blocking the fibroblast growth factor receptor 1, a protein that helps cancer cells grow and spread.
Erdafitinib (Balversa), marketed by Johnson & Johnson, is an FGFR inhibitor approved for locally advanced or metastatic urothelial carcinoma, positioning it in a niche but critical segment of oncology. Its key strength lies in its mechanism of action, which specifically targets the fibroblast growth factor receptor 1, offering a targeted therapy for patients with this receptor alteration. The primary risk to Balversa is the competitive landscape, with several same-class drugs such as pemigatinib, infigratinib, and futibatinib, all of which are patent-protected and have FDA approvals, potentially limiting market share and revenue growth.
At a glance
| Generic name | ERDAFITINIB |
|---|---|
| Sponsor | Johnson & Johnson |
| Drug class | Kinase Inhibitor [EPC] |
| Target | Fibroblast growth factor receptor 1 |
| Modality | Small molecule |
| Therapeutic area | Oncology |
| Phase | FDA-approved |
| First approval | 2019 |
| Annual revenue | 300 |
Mechanism of action
Erdafitinib is kinase inhibitor that binds to and inhibits enzymatic activity of FGFR1, FGFR2, FGFR3 and FGFR4 based on in vitro data. Erdafitinib also binds to RET, CSF1R, PDGFRA, PDGFRB, FLT4, KIT, and VEGFR2. Erdafitinib inhibited FGFR phosphorylation and signaling and decreased cell viability in cell lines expressing FGFR genetic alterations, including point mutations, amplifications, and fusions. Erdafitinib demonstrated antitumor activity in FGFR-expressing cell lines and xenograft models derived from tumor types, including bladder cancer.
Approved indications
- Locally advanced or metastatic urothelial carcinoma
Common side effects
- Phosphate increased
- Stomatitis
- Fatigue
- Creatinine increased
- Diarrhea
- Dry mouth
- Onycholysis
- Alanine aminotransferase increased
- Alkaline phosphatase increased
- Sodium decreased
- Decreased appetite
- Albumin decreased
Key clinical trials
- Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Amplifications (MATCH-Subprotocol K1) (PHASE2)
- Testing JNJ-42756493 (Erdafitinib) as Potentially Targeting Treatment in Cancers With FGFR Mutations or Fusions (MATCH - Subprotocol K2) (PHASE2)
- Testing the Anti-cancer Drug Erdafitinib for Brain Cancers That Have Returned or Progressed Following Treatment (PHASE2)
- 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) (PHASE2)
- Testing Combination Erdafitinib and Enfortumab Vedotin in Metastatic Bladder Cancer After Treatment With Chemotherapy and Immunotherapy (PHASE1)
- Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) (PHASE2)
- A Study of Erdafitinib in Participants With Advanced Solid Tumors and Fibroblast Growth Factor Receptor (FGFR) Gene Alterations (PHASE2)
- An Efficacy and Safety Study of Erdafitinib (JNJ-42756493) in Participants With Urothelial Cancer (PHASE2)
Patents
| Patent | Expiry | Type |
|---|---|---|
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
| FDA Orange Book | Patents + exclusivity |
| SEC EDGAR | Revenue + earnings |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Balversa CI brief — competitive landscape report
- Balversa updates RSS · CI watch RSS
- Johnson & Johnson portfolio CI