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Weekly Digest - Feb 2024
15 Feb 2024: Ministry of Health, Japan, grants priority review for PADCEV and KEYTRUD combination in first-line advanced bladder cancer treatment
- Astellas Pharma Inc. announced that Japan’s Ministry of Health, Labour and Welfare granted priority review for their Supplemental New Drug Application for PADCEV™ with KEYTRUDA® as a combination therapy for first-line treatment of urothelial cancer
- This combination therapy could offer an alternative to platinum-containing chemotherapy, the current standard of care
- The decision for priority review reflects the significance of the Phase 3 EV-302 clinical trial findings, which demonstrated improved overall survival and progression-free survival compared to chemotherapy
- PADCEV with KEYTRUDA is also under review by the European Medicines Agency, and it has been approved by the U.S. Food and Drug Administration.
