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).
“The positive opinion issued by the CHMP for Kyprolis, which, in combination with dexamethasone, achieved superior overall survival versus Velcade and dexamethasone, underscores our commitment to helping patients live better, longer lives,” said David M Reese, MD, senior vice president of Translational Sciences and Oncology at Amgen. “We’re proud to share these results with European regulatory authorities and believe Kyprolis is advancing the standard of care for patients with relapsed or refractory multiple myeloma.”
Kyprolis is approved in the European Union (EU) for use in combination with dexamethasone or with lenalidomide plus dexamethasone (KRd) for the treatment of patients with relapsed or refractory multiple myeloma who have received at least one prior therapy. The Kd regimen of twice-weekly Kyprolis administered at 56mg/m2 and the KRd regimen of twice-weekly Kyprolis administered at 27mg/m2 are the first and only therapeutic combinations to demonstrate consistently improved OS versus recent standards of care in two Phase III trials in relapsed or refractory multiple myeloma patients (Kd versus Vd and KRd versus lenalidomide and dexamethasone).