RTTNews | Dec 17, 2021 07:03AM EST

07:02 Friday, December 17, 2021 (RTTNews.com) - Astellas Pharma Inc. (ALPMY, ALPMY) and Seagen Inc. (SGEN) said the CHMP of the European Medicines Agency has adopted a positive opinion, recommending approval of the antibody-drug conjugate PADCEV or 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 recommendation is based on data from the global phase 3 EV-301 trial. The opinion from the CHMP will now be reviewed by the EC.

Astellas and Seagen are co-developing enfortumab vedotin under a 50:50 worldwide development and commercialization collaboration. Outside of the Americas, Astellas holds responsibility for commercialization activities and regulatory filings.

Read the original article on RTTNews ( https://www.rttnews.com/3250207/astellas-seagen-announce-positive-chmp-opinion-for-padcev-quick-facts.aspx)

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