Janssen's Balversa: EC Decision for Janssen's Balversa in 2L mUC

The European Commision has issued its Decision for Balversa (erdafitinib) for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (mUC), harbouring susceptible FGFR3 genetic alterations who have previously received at least one line of therapy containing a PD-1 or PD-L1 inhibitor in the unresectable or metastatic treatment setting.

This approval is based on results from Cohort 1 of the Phase 3 THOR study (NCT03390504), evaluating the efficacy and safety of erdafitinib (n=136) versus chemotherapy (n=130) in patients with advanced or mUC with select FGFR alterations who have progressed on or after one or two prior treatments, at least one of which includes an anti-PD-(L)1 agent.

Reference link: Janssen press release