What medication is FDA approved for prevention of skeletal-related events (SREs) in multiple myeloma (MM)?

Updated: May 11, 2021
  • Author: Dhaval Shah, MD; Chief Editor: Emmanuel C Besa, MD  more...
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In January 2018, denosumab was approved by the FDA for prevention of skeletal-related events (SREs) in patients with MM. It was originally indicated for SREs in patients with solid tumors. Denosumab is a human monoclonal antibody targeting and binding to receptor activator of nuclear factor kappa-Β ligand (RANKL). Osteoclast-activating factors, such as RANKL, are implicated in an increased risk for SREs with MM.

In a phase III trial of denosumab compared with zoledronic acid in patients (n=1718) with bone metastases, denosumab was noninferior and showed an advantage in significantly reducing the risk for renal adverse events. A post hoc analysis at 15 months was also conducted, since many of the skeletal-related events (60%) occurred early, within 3 months, which led the authors to speculate that the data reflected events occurring before the treatment had enough time to take effect. Results did show superiority of denosumab (n = 450) over zoledronic acid (n = 459) in terms of the endpoint of time to the first SRE (hazard ratio [HR], 0.66; P = 0.039). Median progression-free survival showed difference of more than 10 months was observed between the denosumab (46.09 months) and zoledronic acid (35.38 months) groups (HR, 0.82; P = 0.036). No difference in overall survival was noted between the treatment groups. [121]

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