Amgen Receives CHMP Positive Opinion To Add Updated Overall Survival Data To KYPROLIS ® (carfilzomib) Label

Label Variation to Include Overall Survival Data From Phase 3 ENDEAVOR Trial THOUSAND OAKS, Calif., Jan. 30, 2018 /PRNewswire/ -- Amgen (NASDAQ:AMGN) today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending a label variation for KYPROLIS® (carfilzomib) to include updated overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial in patients with relapsed or refractory multiple myeloma (KYPROLIS and dexamethasone [Kd] versus Velcade® [bortezomib] and dexamethasone [Vd]). The ENDEAVOR trial demonstrated that Kd reduced the risk of death by 21 percent and increased OS by 7....
Source: Amgen News Release - Category: Pharmaceuticals Tags: Uncategorized Source Type: news