Seattle Genetics and Astellas receive FDA breakthrough therapy designation for Padcev (enfortumab vedotin-ejfv) in combination with pembrolizumab in first-line advanced bladder cancer

Seattle Genetics

19 February 2020 - Breakthrough therapy designation based on initial results from Phase 1b/2 EV-103 clinical trial.

Seattle Genetics and Astellas Pharma today announced that the U.S. FDA has granted breakthrough therapy designation for Padcev (enfortumab vedotin-ejfv) in combination with Merck’s anti-PD-1 therapy Keytruda (pembrolizumab) 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 1b/2 trial EV-103 (NCT03288545), evaluating patients with locally advanced or metastatic urothelial cancer who are unable to receive cisplatin-based chemotherapy treated in the first-line setting with Padcev in combination with pembrolizumab.

Read Seattle Genetics press release

Michael Wonder

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Michael Wonder