The FDA on December 15, 2023, approved PADCEV® in combination with Pembrolizumab (KEYTRUDA®) for patients with locally advanced or metastatic Urothelial Cancer. FDA previously granted accelerated approval to this combination for patients with locally advanced or metastatic Urothelial Cancer, who are ineligible for Cisplatin-containing chemotherapy. PADCEV® is a product of Astellas Pharma.