NDA, submitted in March, is for locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication
TOKYO, May 14, 2021 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company’s New Drug Application (NDA), which was submitted in March. If approved, enfortumab vedotin would be the first antibody-drug conjugate (ADC) available in Japan for the treatment of patients with locally advanced or metastatic urothelial cancer that has progressed after anti-cancer medication.
Priority reviews are granted by MHLW for applications based on their clinical usefulness and the seriousness of the diseases for which they are indicated.1 The NDA includes data from the phase 3 EV-301 trial and the phase 2 EV-201 trial, both global clinical trials with investigational sites in Japan.
“The decision by the Ministry of Health, Labour and Welfare to evaluate enfortumab vedotin under priority review reflects the urgent need for new medicines to treat advanced urothelial cancer in Japan, where an estimated 9,500 people die from urothelial cancer each year,” said Andrew Krivoshik, M.D., Ph.D., Senior Vice President and Oncology Therapeutic Area Head, Astellas.2
Urothelial cancer makes up approximately 90 percent of cases of bladder cancer.3 Locally advanced or metastatic urothelial cancer is an aggressive disease that is associated with poor survival and high healthcare costs.4
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