Astellas, Seagen Announce Positive CHMP Opinion For PADCEV - Quick Facts

(RTTNews) - 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.