Amgen has submitted requests to both the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA), to expand the current indication of its drug Xgeva, for the treatment of patients with newly diagnosed Multiple Myeloma (MM).
Xgeva® (denosumab) is a humanized monoclonal antibody against RANK Ligand (RANKL), which prevents binding and activation of its receptor, RANK, in turn decreasing osteoclast formation and survival, and bone resorption. Xgeva currently has approval for the treatment or prevention of skeletal-related events (SREs) in solid tumors, and Amgen now wish to expand this indication to include MM patients with bone lesions. Current treatment options for MM patients with bone lesions are limited to bisphosphonates, such as Zoledronic Acid which can affect kidney function, already heavily compromised in MM patients.
The current application, submitted on 4th April, is supported by new data from a Phase 3 clinical trial (cc'482 study, ClinicalTrials.gov Identifier: NCT01345019) to compare Xgeva with Zoledronic Acid, which was presented at the 16th International Myeloma Workshop (IMW) held in New Delhi from 1st-4th March 2017.