Astellas Submits SNDA In Japan For PADCEV-KEYTRUDA For Advanced Bladder Cancer Treatment

(RTTNews) - Astellas Pharma Inc. (ALPMY, ALPMY) announced the submission of a Supplemental New Drug Application or sNDA to Japan's Ministry of Health, Labour and Welfare for PADCEV with KEYTRUDA as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer.

If approved, PADCEV with KEYTRUDA has the potential to change the treatment paradigm, becoming the first combination treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care in first-line locally advanced or metastatic urothelial cancer, Astellas said in a statement.

The Committee for Medicinal Products for Human Use of the European Medicines Agency is also reviewing the combination therapy. The U.S. Food and Drug Administration approved the combination therapy in December 2023.

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