Posted by Michael Wonder on 26 Mar 2021
European Medicines Agency accepts marketing authorisation application for enfortumab vedotin
26 March 2021 - Enfortumab vedotin to be reviewed under accelerated assessment for the treatment of locally advanced or metastatic urothelial cancer.
Astellas Pharma and Seagen today announced that a marketing authorization application (MAA) for enfortumab vedotin was accepted by the European Medicines Agency.
The marketing authorisation application requests review of enfortumab vedotin for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a programmed death receptor-1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor and who have received a platinum-containing chemotherapy in the neo-adjuvant/adjuvant, locally advanced or metastatic setting.
