Astellas files for Japanese approval of enfortumab vedotin

Japanese drug major Astellas Pharma (TYO: 4503) says it has submitted New Drug Application (NDA) to Japan's Ministry of Health, Labor and Welfare (MHLW) for enfortumab vedotin for the treatment of patients with locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication.

If approved, enfortumab vedotin would be the first antibody-drug conjugate (ADC) available in Japan for people living with this form of urothelial cancer, the most common type of bladder cancer. The only country to have cleared the drug for marketing so far is the USA.

The submission is based on two global clinical trials with sites in Japan. The Phase III EV-301 trial 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. The Phase II EV-201 trial evaluated enfortumab vedotin in patients with locally advanced or metastatic urothelial cancer who have been previously treated with a PD-1/L1 inhibitor, including those who have also been treated with a platinum-containing chemotherapy (cohort 1) and those who have not received a platinum-containing chemotherapy and who are ineligible for cisplatin (cohort 2).