J&J Files NDA for Erdafitinib in Urothelial Cancer Indication

Johnson & Johnson JNJ announced that its subsidiary Janssen has filed a new drug application (“NDA”) seeking approval of its pan-FGFR inhibitor, erdafitinib, as a treatment for metastatic urothelial cancer (“UC”), a type of bladder cancer. The NDA seeks approval of the candidate for treating UC in patients with certain fibroblast growth factor receptor (“FGFR”) genetic alterations and whose tumors have progressed after prior chemotherapy.