SGEN - EMA accepts Astellas Seagen's enfortumab vedotin application in urothelial cancer

The EMA has accepted Astellas Pharma (ALPMF) and Seagen's (SGEN) marketing authorization application ((MAA)) for enfortumab vedotin, for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have received a PD-1 or PD-L1 inhibitor and a platinum-containing chemotherapy in the neoadjuvant/adjuvant setting.If approved, enfortumab vedotin would be the first antibody-drug conjugate ((ADC)) available in the European Union for urothelial cancer. Enfortumab vedotin will be reviewed under accelerated assessment, which means the EMA’s advisory committee can reduce the timeframe for evaluation. The MAA is based on the Phase 3 EV-301 trial, which evaluated enfortumab vedotin versus chemotherapy in urothelial cancer patients, previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.

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EMA accepts Astellas, Seagen's enfortumab vedotin application in urothelial cancer