Johnson & Johnson Receives Full FDA Approval for Balversa in FGFR-Altered Bladder Cancer

Johnson & Johnson today announced that the FDA has converted the accelerated approval of Balversa (erdafitinib) to full approval for the treatment of adults with FGFR-altered locally advanced or metastatic urothelial carcinoma who have received prior platinum-containing chemotherapy and anti-PD-1/L1 therapy. The conversion was based on overall survival data from the Phase 3 THOR trial demonstrating a statistically significant improvement in OS. This full approval reinforces Balversa as a standard of care in FGFR-altered urothelial carcinoma.