FDA Accepts Amgen's Filing Of A Supplemental New Drug Application To Add Overall Survival Results To KYPROLIS ® (Carfilzomib) Label

FDA Sets PDUFA Target Action Date of April 30, 2018 THOUSAND OAKS, Calif., Aug. 30, 2017 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) based on the overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial demonstrating that KYPROLIS® (carfilzomib) and dexamethasone (Kd) reduced the risk of death by 21 percent and increased OS by 7.6 months versus Velcade® (bortezomib) and dexamethasone (Vd) in patients with relapsed or refractory multiple myeloma (median OS 47.6 months for Kd versus 40.0 months for Vd, HR=0.79; p=0.01). The FDA has set a Prescription D...
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news