FDA Grants Erdafitinib Breakthrough Designation for Urothelial Carcinoma

March 15, 2018 – The FDA has granted a breakthrough therapy designation to erdafitinib for the treatment of metastatic urothelial carcinoma, according to Janssen, the manufacturer of the oral pan-FGFR tyrosine kinase inhibitor. The designation, which will expedite the review and development of erdafitinib, is based on the phase II study BLC2001 in which the TKI induced a 42% overall response rate (ORR) in 59 patients with FGFR-positive relapsed/refractory … (leggi tutto)