EU - Janssen submits MAA for Erdafitinib to the EMA in mUC

Janssen has announced the submission of an MAA to the EMA for Erdafitinib for the treatment of adult patients with locally advanced unresectable or metastatic urothelial carcinoma (UC), harbouring susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations, with disease progression during or following at least one line of therapy containing a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-[L]1) inhibitor.

This MAA is supported by data from Cohort 1 of the randomised, controlled, open-label, multicentre Phase 3 THOR study (NCT03390504), evaluating the efficacy and safety of erdafitinib versus chemotherapy. The study met its primary endpoint of overall survival (OS), with patients who received erdafitinib achieving a median OS of over one year at the prespecified interim analysis data cutoff.

Reference link: Janssen press release

On January 19, 2024, the Food and Drug Administration approved erdafitinib (Balversa, Janssen Biotech) for adult patients with locally advanced or metastatic urothelial carcinoma (mUC) with susceptible FGFR3 genetic alterations, as determined by an FDA-approved companion diagnostic test, whose disease has progressed on or after at least one line of prior systemic therapy. Erdafitinib is not recommended for the treatment of patients who are eligible for and have not received prior PD-1 or PD-L1 inhibitor therapy. This approval amends the indication previously granted under accelerated approval for patients with mUC with susceptible FGFR3 or FGFR2 alterations after prior platinum-containing chemotherapy.