FDA Approval Sought for Erdafitinib in Urothelial Carcinoma

September 19, 2018 – A new drug application (NDA) has been submitted to the FDA for erdafitinib for the treatment of patients with locally advanced or metastatic urothelial carcinoma and FGFR genetic alterations whose tumors progressed following chemotherapy, according to Janssen, the manufacturer of the oral pan-FGFR tyrosine kinase inhibitor (TKI). The NDA, which follows a breakthrough therapy designation, is based on the phase II study BLC2001 in which … (leggi tutto)