Seattle Genetics and Astellas' Padcev Wins Breakthrough Therapy Designation in Bladder Cancer

Bladder cancer drug Padcev, which was approved by the U.S. Food and Drug Administration in December, secured Breakthrough Therapy designation for the treatment of patients with another type of bladder cancer. Seattle Genetics and Astellas Pharma, the co-developers of Padcev (enfortumab vedotin-ejfv) said the new designation was awarded to the bladder cancer drug in combination with Merck’s checkpoint inhibitor Keytruda for the treatment of patients with unresectable locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy in the first-line setting. The Breakthrough Therapy designation was granted based on results from the dose-escalation cohort and expansion cohort A of the phase Ib/II trial EV-103, evaluating patients in this setting with the combination treatment. The FDA’s Breakthrough Therapy process is designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition.