Amgen has announced that the European Medicine’s Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation to expand the existing licence for denosumab (Xgeva®) to treat skeletal-related events in myeloma patients.

This decision is based on the results from a Phase III trial which compared denosumab to zoledronic acid (Zometa®). This study demonstrated that denosumab was not inferior to zoledronic acid in terms of delaying time to first on-study SRE.

This indication was also approved by the U.S. Food and Drug Administration (FDA) last month.

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