Denosumab Approaches European Approval for Myeloma

February 23, 2018 – The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of denosumab for the prevention of skeletal-related events (SREs) in patients with multiple myeloma, according to Amgen, the developer of the RANK ligand inhibitor. The CHMP recommendation is based on data from the phase III 482 study, in which denosumab demonstrated noninferiority to zoledronic acid at … (leggi tutto)