J&J announces Phase 1 study of erdafitinib met primary safety endpoint

Johnson & Johnson announced results from an open-label, multicenter Phase 1 study evaluating an investigational intravesical drug-releasing system with erdafitinib in patients with intermediate-risk and high-risk non-muscle-invasive bladder cancer whose tumors harbor select fibroblast growth factor receptor alterations. The study met its primary safety endpoint and demonstrated complete and durable responses in patients with recurrent intermediate-risk disease, along with encouraging recurrence-free outcomes in high-risk disease. These findings support continued development of this targeted approach with ongoing Phase 2 and Phase 3 studies evaluating Erda-iDRS across risk settings. Data were presented during a late-breaking oral session at the European Association of Urology 2026 Annual Meeting