Seattle Genetics, Astellas Get FDA ‘Breakthrough Therapy Designation’ for Enfortumab Vedotin

Seattle Genetics (SGEN) and Astellas Pharma said on Monday that the FDA has granted “breakthrough therapy designation” to enfortumab vedotin, an antibody-drug conjugate (ADC), for patients with locally advanced or metastatic urothelial cancer who were previously treated with checkpoint inhibitors (CPI).

“Breakthrough therapy designation” is a process designed to expedite the development and review of drugs that are intended to treat a serious or life-threatening condition. It is based upon preliminary clinical evidence indicating that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

The FDA Breakthrough Therapy Designation “underscores the potential of enfortumab vedotin as a meaningful treatment for patients with locally advanced or metastatic urothelial cancer,” Seattle Genetics executive Robert Lechleider said in a statement.

“Further, it supports our rapid development plans for this ADC, including the ongoing pivotal study in this patient population,” he added.