Amgen submits regulatory applications to include survival data in KYPROLIS
Amgen announced the submission of a supplemental New Drug Application to the U.S. FDA and a variation to the marketing application to the European Medicines Agency to include overall survival data from the Phase 3 head-to-head ENDEAVOR trial in the product information for KYPROLIS. Data submitted to regulatory authorities showed that KYPROLIS, administered at the 56 mg/m2 dose as a 30-minute infusion twice weekly with dexamethasone, reduced the risk of death by 21% over Velcade and dexamethasone, resulting in a 7.6 month OS 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.