erdafitinib (Balversa): FDA status

Approved Approved Jan 19, 2024. Indication: Locally advanced or metastatic urothelial carcinoma with susceptible FGFR3 alterations after prior therapy. Company: Janssen (Johnson & Johnson).

Regulatory history

• Jan 19, 2024: Approved. FDA converted the 2019 accelerated approval of erdafitinib to full approval for FGFR3-altered urothelial carcinoma based on the phase 3 THOR trial. FDA

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