Astellas Pharma (JP:4503) has released an update.
Japan’s Ministry of Health, Labour and Welfare has approved Astellas Pharma’s PADCEV in combination with KEYTRUDA for first-line treatment of radically unresectable urothelial carcinoma, offering a significant improvement over the current standard platinum-containing chemotherapy. The approval, which is the first of its kind in Japan, was based on a trial that showed nearly doubled median overall survival and significant extension of progression-free survival. The combination therapy has also been approved by the European Commission and the U.S. FDA for similar indications.
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