Posted by Michael Wonder on 03 Sep 2017
FDA accepts Amgen's filing of a supplemental new drug application to add overall survival results to Kyprolis (carfilzomib) label
30 August 2017 - FDA sets PDUFA target action date of 30 April 2018
Amgen today announced that the U.S. FDA has accepted for review a supplemental new drug application based on the overall survival (OS) data from the Phase 3 head-to-head ENDEAVOR trial demonstrating that Kyprolis (carfilzomib) 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).
