Posted by Michael Wonder on 19 Jun 2017
FDA accepts Amgen's supplemental biologics license application to expand indication for Xgeva (denosumab) to include multiple myeloma patients
19 June 2017 - FDA sets PDUFA target action date of 3 February 2018.
Amgen today announced that the U.S. FDA has accepted the Xgeva (denosumab) supplemental biologics license application that seeks to expand the currently approved indication for the prevention of fractures and other skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
The application, submitted on April 3, 2017, is based on the efficacy and safety data from the pivotal Phase 3 '482 study, the largest international multiple myeloma trial ever conducted, which successfully demonstrated that XGEVA is non-inferior to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma. The secondary endpoints of superiority in delaying time to first on-study skeletal-related event and delaying time to first-and-subsequent skeletal-related event were not met in this study. Progression-free survival was an exploratory endpoint. The hazard ratio of XGEVA versus zoledronic acid for progression-free survival was 0.82 (95% CI: 0.68, 0.99; descriptive p=0.036) and the median difference in progression-free survival between arms was 10.7 months in favour of XGEVA. Data from the '482 study are also the basis of an application for a variation to the marketing authorisation submitted to the EMA.
