Drug updated on 4/18/2024
| 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.
Summary
- Erdafitinib (Balversa) is 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.
- Two studies were reviewed to gather information about this drug.
- The safety profile of erdafitinib was highlighted in these reviews, noting that common all-grade adverse events include hyperphosphatemia, dry mouth, stomatitis, diarrhea, and dysgeusia; serious adverse events were less frequent but included stomatitis and hyponatremia.
- In terms of efficacy comparison with other therapies, erdafitinib's effectiveness in treating metastatic urothelial carcinoma was significantly better compared to its efficacy in other solid tumors - an objective response rate of 0.38 versus 0.10, respectively.
- The highest efficacy from erdafitinib use occurred in patients with specific FGFR genetic alterations (FGFR3-TACC3), indicating a genetically defined subgroup where this drug's effectiveness is maximized.
- These findings underscore the importance of genetic profiling when considering treatment strategies involving erdafitinib, as it offers a significant therapeutic advantage over broader-spectrum therapies for a genetically defined subgroup within the cancer patient population.
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. | 2023 | Frontiers in Oncology |
| Fibroblast growth factor receptor: a systematic review and meta-analysis of prognostic value and therapeutic options in patients with urothelial bladder carcinoma. | 2021 | Urologic Oncology: Seminars and Original Investigations |
Clinical Practice Guidelines
| Document Title | Year | Source |
|---|---|---|
| Bladder cancer: ESMO clinical practice guideline for diagnosis, treatment and follow-up. | 2021 | Annals of Oncology |
| Bladder cancer, version 3.2020 | 2020 | Journal of the National Comprehensive Cancer Network |