Posted by Michael Wonder on 15 Mar 2018
Janssen announces U.S. FDA breakthrough therapy designation for erdafitinib in the treatment of metastatic urothelial cancer
15 March 2018 - Erdafitinib, an oral pan-fibroblast growth factor receptor tyrosine kinase inhibitor, shows promise as the first targeted agent for patients with metastatic urothelial cancer, one of the most common cancers.
The Janssen Pharmaceutical Companies of Johnson & Johnson announced today that the U.S. FDA has granted breakthrough therapy designation for erdafitinib in the treatment of urothelial cancer. Urothelial cancer, most frequently in the bladder, is the sixth most common type of cancer in the U.S.
The breakthrough therapy designation is based on data from a multicenter, open-label Phase 2 clinical trial evaluating the efficacy and safety of erdafitinib in the treatment of adult patients with locally advanced or metastatic urothelial cancer, whose tumours have certain fibroblast growth factor receptor genetic alterations.
