Amgen has announced it has submitted respective applications to the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) to expand the currently approved indication for denosumab (Xgeva®) to include myeloma patients. At present, denosumab is licensed for the prevention of skeletal-related events (SREs) in solid cancer patients but results from a recent head-to-head Phase III trial of denosumab versus zoledronic acid for newly diagnosed myeloma patients showed that it was equally effective in delaying the time to first on-study SRE as zoledronic acid. Decisions from both regulatory bodies are expected in 2018.


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