TOKYO and BOTHELL, Wash. – February 28, 2022 -- 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 confirmed its previously adopted positive opinion, recommending approval of 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.
The CHMP initially adopted a positive opinion of enfortumab vedotin on December 16, 2021, providing its recommendation to the European Commission (EC) for a final decision. During the EC’s decision-making process, further safety information was brought to the attention of the CHMP. Following a request from the EC and taking into account the latest information, the CHMP re-adopted its positive opinion.1 If approved by the EC, enfortumab vedotin will be the first antibody-drug conjugate authorized in the European Union for people living with advanced urothelial cancer.
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.2
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