PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) Granted Priority Review by Japan's Ministry of Health, Labour and Welfare fo...
ASTELLAS PHARMA UNSP/ADR (ALPMY)
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Source: Yahoo! Finance
extended overall survival and progression free survival compared to platinum-containing chemotherapy- TOKYO Feb. 15, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura , "Astellas") today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company's Supplemental New Drug Application (sNDA) for PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA ® (pembrolizumab (genetical recombination)) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). The sNDA was submitted in January 2024 . 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 la/mUC. Priority reviews are granted by MHLW for applications based on
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