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Astellas Submits New Drug Application for Enfortumab Vedotin in Japan


Press release content from PR Newswire. The AP news staff was not involved in its creation.
Astellas Submits New Drug Application for Enfortumab Vedotin in Japan
March 11, 2021 GMT
Astellas is a pharmaceutical company dedicated to improving the health of people around the world. (PRNewsFoto/Astellas Pharma Inc.)
Astellas is a pharmaceutical company dedicated to improving the health of people around the world. (PRNewsFoto/Astellas Pharma Inc.)
TOKYO, March 11, 2021 /PRNewswire/ Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the submission of a New Drug Application (NDA) to Japan’s Ministry of Health, Labour 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 wit ....

United States , Al Iskandariyah , Ministry Of Health , Al Qahirah , Kenji Yasukawa , Andrew Krivoshik , Enfortumab Vedotin , American Society Of Clinical Oncology , Value Health , Cancer Information Service , Seagen Inc , Astellas Pharma Inc , Japan Ministry Of Health , Prnewswire Astellas Pharma Inc , New Drug Application , Senior Vice President , Oncology Therapeutic Area Head , New England Journal , Clinical Oncology , Clinical Oncology Genitourinary Cancer , Seagen Collaboration , Focus Area Approach , Evaluate Enfortumab Vedotin Versus , Subjects With Previously Treated Locally Advanced , Metastatic Urothelial Cancer , Accessed January ,