Denosumab approved for MM in Europe

On 2 April 2018, Amgen announced an expansion of the treatment indication for denosumab by the European Commission, which is now available to treat skeletal-related events (SREs) in adult patients with multiple myeloma (MM). This indication will span all 28 countries that are members of the European Union (EU). Denosumab, the first fully humanized monoclonal antibody that binds to and neutralizes RANK ligand (RANKL), was recently granted FDA approval for this indication – read here.

The results of a phase III, international trial – previously described in an MM Hub article, included 1,718 patients at 259 medical centers in 29 countries, and demonstrated non-inferiority of denosumab in comparison to the bisphosphonate zoledronic acid (ZA), in terms of delaying the time to the first SRE in MM patients. Additionally, the study displayed a significant improvement in the median progression-free survival (PFS) with the use of denosumab.

The major advantage of denosumab is safety in patients with renal impairment, and whilst the greater cost of denosumab compared to ZA could be a drawback, whereas recent cost-effectiveness analyses seem to suggest otherwise – read here.