- If approved, PADCEV would be the first medicine for patients in the EU who have received prior platinum-based chemotherapy and a PD-1/L1 inhibitor -

TOKYO and BOTHELL, Wash. – December 17, 2021 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending approval of the antibody-drug conjugate (ADC) PADCEV™ (enfortumab vedotin) as monotherapy for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received platinum-containing chemotherapy and a PD-1/L1 inhibitor.1

Urothelial cancer is the most common type of bladder cancer.2 In Europe, an estimated 204,000 people were diagnosed with urothelial cancer in 2020, and more than 67,000 died as a result of the disease.3 If approved by the European Commission (EC), enfortumab vedotin will be the first ADC authorized in the European Union for people living with advanced urothelial cancer.

“People with advanced bladder cancer have few treatment options after platinum-based chemotherapy and immunotherapy,” said Ahsan Arozullah, M.D., M.P.H., Vice President, Medical Sciences-Oncology, Astellas. “The CHMP's positive opinion is an important step as we work to expand availability of enfortumab vedotin as quickly as possible.”

The CHMP recommendation is based on data from the global phase 3 EV-301 trial, which evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. Results from the trial, which had a primary endpoint of overall survival, were published in the New England Journal of Medicine.

The positive opinion from the CHMP will now be reviewed by the EC. EC decisions are valid in the European Union Member States, as well as Iceland, Norway and Liechtenstein.4


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