European Medicines Agency accepts marketing authorisation application for enfortumab vedotin (EV) for the treatment of locally advanced or metastatic urothelial cancer
EV is an antibody-drug conjugate directed against Nectin-4, a protein highly expressed in bladder cancer. The application is based on data from the EV-301 trial which compared it to chemotherapy in adult previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor
Source:
Biospace Inc.
SPS commentary:
The EV-301 RCT (n=608) found that enfortumab vedotin significantly prolonged overall survival when compared to investigator’s choice of standard chemotherapy (docetaxel, paclitaxel, or vinflunine) in adults who had previously received platinum-based treatment and a programmed cell death protein 1 (PD-1) or programmed death ligand 1 (PD-L1) inhibitor (median 12.88 vs 8.97 months; HR 0.70; P=0.001).
Enfortumab vedotin will be reviewed under accelerated assessment, which means the EMA’s Committee for Medicinal Products for Human Use (CHMP) can reduce the timeframe for evaluation.