FGFR inhibitor erdafitinib for urothelial cancer is filed in Japan – Janssen Pharmaceutical

Janssen Pharmaceutical has filed a new drug application in Japan for its oral fibroblast growth factor receptor (FGFR) tyrosine kinase inhibitor erdafitinib for the treatment of certain patients with urothelial cancer. The drug, sold under the brand name Balversa overseas, was submitted for use in adult patients with unresectable urothelial carcinoma harboring FGFR3 genetic mutations or FGFR3 gene fusion alterations, with disease progression following cancer drug therapy.

The submission is supported by data from Cohort 1 of the global PIII THOR study, which assessed the efficacy and safety of erdafitinib in patients with advanced urothelial cancer harboring FGFR aberrations who have progressed after at least one line of treatment including a PD-1 or PD-L1 inhibitor. In the randomized, open-label, multicenter study, which enrolled Japanese patients as well, erdafitinib demonstrated a 36% reduction in the risk of deaths as compared to chemotherapy.