17 January 2018 - Phase 3 data showed Kyprolis and dexamethasone reduced the risk of death by 21% 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.
Amgen today announced that the U.S. FDA has approved the supplemental new drug application 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 dexamethasone (Kd) reduced the risk of death by 21% 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).