This story originally appeared on Zacks
Seagen Inc. SGEN and partner Astellas Pharma Inc. announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (“CHMP”) has rendered a positive opinion on, and has recommended marketing authorization to its an antibody-drug conjugate (“ADC”), Padcev (enfortumab vedotin). The CHMP recommended approval of Padcev as a monotherapy for the treatment of locally advanced or metastatic urothelial cancer in adult patients who have previously received platinum-containing chemotherapy and a PD-1/L1 inhibitor.
The positive CHMP opinion was based on data from the phase III EV-301 study, which evaluated enfortumab vedotin versus chemotherapy in the given patient population. The study had a primary endpoint of overall survival.
The opinion will now be reviewed by the European Commission. If approved, Padcev will become the first ADC authorized for patients with advanced urothelial cancer…