J&J gains EC approval for Balversa

The European Commission (EC) has approved Balversa (erdafitinib) from US healthcare giant Johnson & Johnson (NYSE: JNJ) in bladder cancer.

Balversa is as a once-daily oral monotherapy authorized for the treatment of adult patients with unresectable or metastatic urothelial carcinoma (mUC), harboring 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.2

“Bladder cancer is one of Europe’s most common cancers and the need for innovative treatment options for people living with unresectable or metastatic urothelial carcinoma remains high,” said Dr Yohann Loriot, of the Institut Gustave Roussy and University of Paris-Saclay, France, adding: “Erdafitinib is a novel, targeted therapy that has been shown to significantly improve overall and progression-free survival for patients with FGFR3 alterations, who, until now, have had limited options available.”