Posted by Michael Wonder on 09 Sep 2023
Janssen submits marketing authorisation application to the EMA seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer with susceptible FGFR alterations
8 September 2023 - The submission is based on results from the Phase 3 THOR study, which were featured in a Late-Breaking Presentation Session at the 2023 ASCO Annual Meeting in June.
Janssen announced today the submission of a marketing authorisation application to the EMA seeking approval of erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma, harbouring susceptible fibroblast growth factor receptor 3 genetic alterations, with disease progression during or following at least one line of therapy containing a programmed death receptor-1 or programmed death-ligand 1 inhibitor.
