14 July 2017 - Data showed Kyprolis and dexamethasone reduced the risk of death by 21% and increased overall survival by 7.6 months compared to Velcade (bortezomib) and dexamethasone in relapsed or refractory multiple myeloma patients.

Amgen today announced the submission of a supplemental new drug application to the U.S. FDA and a variation to the marketing application to the EMA to include overall survival data from the Phase 3 head-to-head ENDEAVOR trial in the product information for Kyprolis (carfilzomib).

Data submitted to regulatory authorities showed that Kyprolis, administered at the 56 mg/m2 dose as a 30-minute infusion twice weekly with dexamethasone (Kd56), reduced the risk of death by 21 percent over Velcade (bortezomib) and dexamethasone (Vd), resulting in a 7.6 month overall survival benefit (median OS 47.6 months for Kd56 versus 40.0 months for Vd, HR=0.79; p=0.01). The OS benefit was consistent regardless of prior bortezomib therapy (HR 0.75 for no prior Velcade; HR 0.84 for prior Velcade). These results were presented earlier this year at the 16th International Myeloma Workshop and the 22nd Congress of the European Hematology Association.

Read Amgen press release