Kyprolis label variation for refractory multiple myeloma

Amgen has 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 III 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 7.6 months versus 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).