EC green light for Padcev in urothelial cancer

14 April 2022

The European Commission (EC) has approved Padcev (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a platinum-containing chemotherapy and a PD-1/L1 inhibitor.

Awarded to Japanese pharma major Astellas Pharma (TYO: 4503) and partner US biotech Seagen (Nasdaq: SGEN), the EC approval is supported by data from the global Phase III EV-301 trial that demonstrated an overall survival (OS) benefit compared with chemotherapy.

“The approval of enfortumab vedotin in the European Union is a significant milestone for people living with advanced urothelial cancer who have had limited treatment options and poor survival rates,” said Dr Ahsan Arozullah, vice president, medical sciences-oncology, Astellas, adding: “We look forward to working with health authorities to ensure people living with advanced urothelial cancer can access this new treatment option as soon as possible.”

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