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.
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