Janssen seeking full approval of erdafitinb in 2L+ mUC
Janssen announced supplemental NDA filing to the FDA (Aug 28th, 2023) and Marketing Authorisation Application (MAA) submission to the European Medicines Agency (EMA; Sept 8th, 2023) seeking full approval of erdafitinb (FGFRi) in 2L+ (including at least one line of PD-[L]1) FGFR3alt la/mUC (est. ~15-20% of mUC).
Submissions are based on results from Cohort 1 of the confirmatory P3 THOR trial, presented at ASCO 2023 (Abstract #LBA4619)
Phase 3 THOR trial met its primary endpoint of OS with erdafitinib demonstrating mOS 12.1 months (vs 7.8 mo chemo; HR 0.64) at the pre-specified interim analysis data cut-off at 1 year
US approval would build on prior 2019 US accelerated approval for erdafitinib (2L+ FGFR2/3alt mUC following platinum-containing chemo)
Strong Phase 3 results and full global approvals could increase FGFR testing and 2L uptake.