NEW YORK (GenomeWeb) – Janssen will pursue US marketing approval for the FGFR inhibitor erdafitinib after a Phase II study showed the drug shrunk tumors in 40 percent of patients with advanced urothelial cancer and FGFR mutations.

The Phase II trial, presented earlier this month at the American Society of Clinical Oncology annual meeting, enrolled 99 patients with metastatic or surgically unresectable, locally advanced urothelial cancer. All patients had FGFR fusions or mutations determined by central lab testing and received erdafitinib.