Posted by Michael Wonder on 26 Mar 2018
Seattle Genetics and Astellas receive FDA breakthrough therapy designation for enfortumab vedotin in locally advanced or metastatic urothelial cancer
26 March 2018 - Seattle Genetics and Astellas Pharma today announced that the U.S. FDA has granted breakthrough therapy designation to enfortumab vedotin, an antibody-drug conjugate, for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors.
The breakthrough therapy designation was granted based on interim results from the phase 1 study examining enfortumab vedotin as monotherapy treatment for patients with metastatic urothelial cancer who were previously treated with CPIs. Enfortumab vedotin is being studied in a pivotal clinical trial, EV-201 (NCT03219333), as monotherapy in this patient setting and in an early-phase clinical trial in combination with checkpoint inhibitor therapy, EV-103 (NCT03288545).
The companies are also evaluating enfortumab vedotin in other solid tumours, including ovarian and non-small cell lung carcinoma.
