Johnson & Johnson Receives FDA Approval for Balversa in FGFR-Altered Urothelial Carcinoma

Johnson & Johnson today announced that the FDA has granted regular approval to Balversa (erdafitinib) for adults with locally advanced or metastatic urothelial carcinoma (UC) with susceptible FGFR3 or FGFR2 genetic alterations that have progressed during or following at least one line of prior platinum-containing chemotherapy. In the Phase 3 THOR trial, Balversa demonstrated a statistically significant improvement in overall survival compared to chemotherapy or pembrolizumab. The median OS was 12.1 months for Balversa versus 7.8 months for the comparator arm. This regular approval converts the previous accelerated approval of Balversa in FGFR-altered UC.