FDA Approves Addition Of Positive Overall Survival Data From Phase 3 ASPIRE Trial To KYPROLIS ® (carfilzomib) Label

KYPROLIS, Lenalidomide and Dexamethasone Extended Median Overall Survival in Relapsed or Refractory Multiple Myeloma Patients to 48 Months KYPROLIS is the First and Only Treatment to Demonstrate Overall Survival Benefits in Two Phase 3 Studies in Relapsed or Refractory Multiple Myeloma THOUSAND OAKS, Calif., June 11, 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 the positive overall survival (OS) data from the Phase 3 ASPIRE trial to the U.S. Prescribing Information for KYPROLIS® (carfilzomib). Data added to the label showed that KYPROLIS, lenalidomide and dexam...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news