ALPMF - Seagen Astellas' Padcev OK'd in Japan for advanced urothelial cancer

Astellas Pharma (OTCPK:ALPMY) and Seagen (NASDAQ:SGEN) have announced that Japan's Ministry of Health, Labour and Welfare has approved PADCEV (enfortumab vedotin) for radically unresectable urothelial carcinoma that has progressed after anti-cancer chemotherapy. The New Drug Application received priority review. The approval is primarily based on Phase 3 EV-301 clinical 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. Radically unresectable urothelial carcinoma is urothelial cancer that cannot be treated by surgical removal of the urinary bladder or the kidney and the ureter due to tumor growth.

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Seagen, Astellas' Padcev OK'd in Japan for advanced urothelial cancer