FDA approved erdafitinib for FGFR3-altered metastatic urothelial carcinoma in 2024
The agency cleared Balversa for patients with locally advanced or metastatic urothelial carcinoma whose disease had progressed after prior therapy.
The Food and Drug Administration approved erdafitinib, marketed as Balversa by Janssen Biotech, on January 19, 2024. The approval covers locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 genetic alterations in patients whose disease has progressed on or after at least one line of prior systemic therapy.1
The document provided does not include additional details such as the specific clinical trial data, dosing regimen, or companion diagnostic information that typically accompany such approvals. Readers seeking those specifics should consult the full prescribing information or the FDA's complete approval record.
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