BRIEF—Janssen files for erdafitinib approval in EU

The Johnson & Johnson subsidiary Janssen has submitted a Marketing Authorization Application to the European Medicines Agency seeking approval of erdafitinib for the treatment of patients with locally-advanced or metastatic urothelial cancer with susceptible pan-fibroblast growth factor receptor (FGFR) alterations.

Pending approval, erdafitinib, an investigational, once-daily oral pan-FGFR tyrosine kinase inhibitor, will become the first therapy targeting FGFR alterations in patients with metastatic urothelial carcinoma, one of Europe’s most common cancers.

The submission is based on results from the Phase III THOR study.