23 August 2024 - Approval based on THOR results, showing 36 percent reduction in risk of death with erdafitinib versus chemotherapy.

Janssen-Cilag today announced that the European Commission has approved Balversa (erdafitinib) as a once daily oral monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma, harbouring susceptible fibroblast growth factor receptor 3 genetic alterations who have previously received at least one line of therapy containing a programmed death receptor-1 or programmed death-ligand 1 inhibitor in the unresectable or metastatic treatment setting.

Read Janssen press release