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Balversa

erdafitinib
FGFR Kinase Inhibitor FDA Approved 2019 Janssen
Route
Oral
Half-Life
~59 hrs
FDA Approved
2019
Manufacturer
Janssen
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1. Indications and Usage

Urothelial carcinoma: FGFR-altered locally advanced/metastatic UC after prior therapy.

2. Dosage and Administration

8 mg daily, may increase to 9 mg based on phosphate levels.

3. Dosage Forms and Strengths

Tablets: 3 mg, 4 mg, 5 mg

4. Contraindications

None listed.

5. Warnings and Precautions
  • Ocular Toxicity: CSR/RPED reported. Ophthalmologic exams.
  • Hyperphosphatemia: 77%. Restrict phosphate.
  • Embryo-Fetal Toxicity: Can cause fetal harm.
6. Adverse Reactions
Most Common Adverse Reactions

Hyperphosphatemia (77%), Stomatitis (58%), Fatigue (55%), Nail Toxicity (54%), Diarrhea (51%), Dry Mouth (46%), Dysgeusia (40%), Alopecia (37%)

Hyperphosphatemia
77%
Stomatitis
58%
Fatigue
55%
Nail Toxicity
54%
Diarrhea
51%
Dry Mouth
46%
Dysgeusia
40%
Alopecia
37%

Consult the complete prescribing information for a comprehensive list of adverse reactions and their frequencies.

7. Drug Interactions

CYP3A4 Inducers: Avoid strong inducers.

8. Use in Specific Populations
Pregnancy

Consult the full prescribing information for pregnancy-related considerations.

Lactation

Refer to prescribing information for lactation guidance.

Pediatric Use

Pediatric safety and efficacy information is detailed in the full label.

Hepatic/Renal Impairment

Dose modifications for organ impairment are specified in the complete prescribing information.

12. Clinical Pharmacology
Mechanism of Action

Pan-FGFR inhibitor binding FGFR1-4, blocking FGFR-mediated signaling in cells with FGFR alterations.

Pharmacokinetics

Tmax: 2.5h. Protein binding: 99.8%. t½: 59h.

14. Clinical Studies

Clinical efficacy and safety data supporting the approval are available in the full prescribing information and from the clinical trials listed below.

Pivotal Clinical Trials
Additional Resources
📋 All Balversa Trials on ClinicalTrials.gov ↗ 📚 PubMed: Balversa Clinical Trials ↗
FDA-Approved Tumor Types

Balversa has FDA-approved indications across the following cancer types covered on CancerDrugEvidence:

Bladder Cancer
External Resources
📋 DailyMed Label ↗ 🏛️ FDA Drugs@FDA ↗ 🔬 ClinicalTrials.gov ↗ 📚 PubMed Pivotal Trials ↗
Important Notice: This page is intended as a navigational reference to the FDA-approved prescribing information for Balversa. It does not replace the full prescribing information. Healthcare professionals should consult the complete package insert available at DailyMed before making prescribing decisions. Patient-specific factors should always guide clinical decision-making.

Frequently Asked Questions

What is Balversa (erdafitinib) approved for?

Balversa (erdafitinib) is an FDA-approved oncology agent. Refer to the full prescribing information for complete indication details.

How is Balversa (erdafitinib) administered?

Refer to the full prescribing information for dosing schedules, administration instructions, and dose modifications.

How does Balversa (erdafitinib) work?

Pan-FGFR inhibitor binding FGFR1-4, blocking FGFR-mediated signaling in cells with FGFR alterations.

What are the most common side effects?

Hyperphosphatemia (77%), Stomatitis (58%), Fatigue (55%), Nail Toxicity (54%), Diarrhea (51%), Dry Mouth (46%), Dysgeusia (40%), Alopecia (37%) Hyperphosphatemia 77% Stomatitis 58% Fatigue 55% Nail Toxicity 54% Diarrhea 51% Dry Mouth 46% Dysgeusia 40% Alopecia 37%

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