Positive CHMP opinion for Padcev in locally advanced or metastatic urothelial cancer.
Urothelial cancer is the most common type of bladder cancer. In Europe, an estimated 204,000 people were diagnosed with urothelial cancer in 2020, and more than 67,000 died as a result of the disease. If approved by the European Commission (EC), enfortumab vedotin will be the first ADC authorized in the European Union for people living with advanced urothelial cancer.
The CHMP recommendation is based on data from the global phase III EV-301 trial, which evaluated enfortumab vedotin versus chemotherapy in adult patients with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor. Results from the trial, which had a primary endpoint of overall survival, were published in the New England Journal of Medicine.(previously cited).
Learning Zones
The Learning Zones are an educational resource for healthcare professionals that provide medical information on the epidemiology, pathophysiology and burden of disease, as well as diagnostic techniques and treatment regimens.
3 mins