ARTICLE | Company News
EC expands Kyprolis label
July 6, 2016 12:12 AM UTC
Amgen Inc. (NASDAQ:AMGN) said the European Commission approved Kyprolis carfilzomib in combination with dexamethasone to treat multiple myeloma in adults who have received at least one prior therapy. The selective proteasome inhibitor previously was approved in the EU in combination with Revlimid lenalidomide and dexamethasone.
The expanded approval was based on results from Amgen's Phase III ENDEAVOR study in which Kyprolis plus dexamethasone was superior to Velcade bortezomib plus dexamethasone as a second-line treatment in MM patients (see BioCentury Extra, March 2, 2015). ...