Drug updated on 10/29/2024
| Dosage Form | Tablet (oral; 3 mg, 4 mg, 5 mg) |
| Drug Class | Kinase inhibitors |
| Ongoing and Completed Studies | ClinicalTrials.gov |
Indication
- 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.
Latest News
Summary
- This summary is based on the review of one systematic review(s)/meta-analysis(es). [1]
- Erdafitinib demonstrated an objective response rate (ORR) of 0.38 in urothelial carcinoma patients, compared to a lower ORR of 0.10 in patients with other solid tumors, indicating higher effectiveness in the urothelial carcinoma population.
- The progressive disease rate (PDR) was 0.26 for urothelial carcinoma patients, significantly lower than the 0.68 PDR for other solid tumors, suggesting better disease control in urothelial carcinoma.
- All responses occurred in patients with FGFR (fibroblast growth factor receptor) alterations, with the FGFR3-TACC3 alteration subgroup showing the highest response, indicating targeted effectiveness in this genetic subgroup.
- Common all-grade adverse events for erdafitinib included hyperphosphatemia, dry mouth, stomatitis, diarrhea, and dysgeusia.
- The most common Grade ≥3 adverse events were stomatitis and hyponatremia, and eye disorders were highlighted as a significant safety concern.
- Erdafitinib showed significantly better effectiveness in advanced and metastatic urothelial carcinoma patients compared to those with other solid tumors, with all responses occurring in patients with FGFR alterations, particularly in the FGFR3-TACC3 subgroup, which exhibited the highest response.
Product Monograph / Prescribing Information
| Document Title | Year | Source |
|---|---|---|
| Balversa (erdafitinib) Prescribing Information. | 2024 | Janssen Products, LP, Horsham, PA |
Systematic Reviews / Meta-Analyses
| Document Title | Year | Source |
|---|---|---|
| Safety and efficacy of the pan-FGFR inhibitor erdafitinib in advanced urothelial carcinoma and other solid tumors: A systematic review and meta-analysis | 2022 | Frontiers in Oncology |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Bladder cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. | 2022 | Annals of Oncology |
| FGFR Inhibitors in Oncology: Insight on the Management of Toxicities in Clinical Practice. | 2021 | Cancers |
| Bladder Cancer, Version 3.2020, NCCN Clinical Practice Guidelines in Oncology. | 2020 | Journal of the National Comprehensive Cancer Network |