FDA Grants Enfortumab Vedotin Breakthrough Designation for Urothelial Carcinoma

March 26, 2018 – The FDA has granted enfortumab vedotin a breakthrough therapy designation for patients with locally advanced or metastatic urothelial cancer who previously received immune checkpoint therapy, according to Seattle Genetics and Astellas, the manufacturers of the antibody-drug conjugate (ADC). The breakthrough therapy designation, which will expedite the development and review of the ADC, was granted based on interim results from a phase I … (leggi tutto)