FDA Approves Addition Of Overall Survival Data To KYPROLIS ® (carfilzomib) Label

Phase 3 Data Showed KYPROLIS and Dexamethasone Reduced the Risk of Death by 21 Percent Versus Velcade® (Bortezomib) and Dexamethasone in Patients With Relapsed or Refractory Multiple Myeloma Overall Survival Results Support Use of KYPROLIS in Combination With Dexamethasone as New Standard of Care THOUSAND OAKS, Calif., Jan. 17, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental New Drug Application (sNDA) to add overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial to the Prescribing Information for KYPROLIS® (carfilzomib). Data added to the label demonstrated that KYPROLIS and dexam...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news