China's National Medical Products Administration Accepts Astellas and Pfizer's Supplemental Biologics License Application for enfortumab vedotin with KEYTRUDA® (pembrolizumab) for First-Li...
Pfizer, Inc. (PFE)
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Source: Yahoo! Finance
- If approved, enfortumab vedotin with KEYTRUDA would be the first combination in China to offer an alternative to chemotherapy, the current standard of care in first-line locally advanced or metastatic urothelial cancer- TOKYO March 28, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura , "Astellas") today announced that on March 27, 2024 the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBLA) for enfortumab vedotin with KEYTRUDA ® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). If approved, enfortumab vedotin 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
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