Posted by Michael Wonder on 19 Sep 2018
Janssen submits new drug application to U.S. FDA seeking approval of erdafitinib for the treatment of metastatic urothelial cancer
18 September 2018 - Janssen announced today that a new drug application has been submitted to the U.S. FDA seeking approval of erdafitinib for the treatment of patients with locally advanced or metastatic urothelial cancer and certain fibroblast growth factor receptor genetic alterations whose tumours have progressed after prior chemotherapy.
Erdafitinib is an investigational, once-daily, oral pan-FGFR inhibitor that received breakthrough therapy designation from the FDA in March 2018.
The submission is based on data from the BLC2001 (NCT02365597) Phase 2 clinical trial, which evaluated the efficacy and safety of erdafitinib in the treatment of adult patients with locally advanced or metastatic UC, whose tumors have certain FGFR alterations.
