Amgen Submits Regulatory Applications In US And Europe To Include Overall Survival Data In KYPROLIS ® (Carfilzomib) Label

Data Showed KYPROLIS and Dexamethasone Reduced the Risk of Death by 21 Percent and Increased Overall Survival by 7.6 Months Compared to Velcade® (Bortezomib) and Dexamethasone in Relapsed or Refractory Multiple Myeloma Patients THOUSAND OAKS, Calif., July 14, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) and a variation to the marketing application to the European Medicines Agency (EMA) to include overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial in the product information for KYPROLIS® (carfilzomib). Data submitted to regulatory authorities sho...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news