August 24, 2024 – Janssen-Cilag International NV, a Johnson & Johnson company, today announced that the European Commission (EC) has approved BALVERSA?▼(erdafitinib) as a once-daily oral monotherapy for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (mUC), harbouring susceptible fibroblast growth factor receptor 3 (FGFR3) genetic alterations who have previously received at least one line of therapy containing a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in the unresectable or metastatic treatment setting. First pan FGFR kinase inhibitor to be approved in the European Economic Area, for adults with unresectable or metastatic urothelial carcinoma and susceptible FGFR3 alterations.
This approval based on THOR results, showing 36 percent reduction in risk of death with erdafitinib versus chemotherapy. THOR is a Phase 3 randomised, open-label, multicentre study evaluating the efficacy and safety of erdafitinib. All patients included in the study had metastatic or unresectable UC,with selected FGFR genetic alterations and showed disease progression during or after one or two prior lines of treatment.
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