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.
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April 17, 2026 15:29 ET The ongoing conflict in the Middle East continues to raise concerns for policymakers who worry about the impact of the supply shock and high energy prices on the real economy. Producer price data and various survey results on the housing market were the main news from the U.S. this week. In Europe, industrial production data for the euro area gained attention. GDP figures out of China and the policy move by the Singapore central bank were in focus in Asia.