Posted by Michael Wonder on 28 Feb 2022
Astellas and Seagen announce CHMP confirms positive opinion for Padcev (enfortumab vedotin) in locally advanced or metastatic urothelial cancer
28 February 2022 - Astellas Pharma and Seagen today announced that the CHMP of the 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 16 December 2021, providing its recommendation to the European Commission for a final decision. During the European Commission's decision-making process, further safety information was brought to the attention of the CHMP. Following a request from the European Commission and taking into account the latest information, the CHMP re-adopted its positive opinion. If approved by the European Commission, enfortumab vedotin will be the first antibody-drug conjugate authorised in the European Union for people living with advanced urothelial cancer.
