FDA Grants Enfortumab Vedotin Priority Review for Urothelial Cancer

Sep 16, 2019 – The FDA has granted a priority review designation to a biologics license application (BLA) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer who have received prior treatment with a PD-1/PD-L1 inhibitor and platinum-containing chemotherapy in the neoadjuvant/adjuvant, locally advanced, or metastatic setting. The designation is based on results from the first cohort of patients in the phase II EV-201 … (leggi tutto)