Summary

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• Balversa (erdafitinib) 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.
• This summary is based on the review of two systematic review(s)/meta-analysis(es). ^[1-2]
• Erdafitinib demonstrated an Objective Response Rate (ORR) of 38% in patients with advanced and metastatic urothelial carcinoma, compared to 10% in patients with other solid tumors. The Progressive Disease Rate (PDR) was 26% in urothelial carcinoma and 68% in other solid tumors.
• All responses to erdafitinib occurred in patients with FGFR alterations, with the highest response observed in those with the FGFR3-TACC3 alteration.
• In comparison with other drugs such as dovitinib and infigratinib, erdafitinib's Overall Response Rate (ORR) was reported at 40%, with Complete Response Rates ranging from 0% to 8% and Disease Control Rates between 59.3% and 64.2%.
• Common all-grade adverse events associated with erdafitinib include hyperphosphatemia, dry mouth, stomatitis, diarrhea, and dysgeusia. Common ≥3 adverse events include stomatitis and hyponatremia.
• Eye disorders were identified as a significant safety concern, though no specific population subgroup was highlighted. The overall toxicity profile of erdafitinib was considered acceptable.
• FGFR3 mutation in NMIBC is a prognostic factor for recurrence-free survival and progression-free survival.