Xgeva® (denosumab): Risk of new primary malignancy

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Description:

New primary malignancies have been reported more frequently in patients treated with Xgeva® (denosumab 120mg once monthly) compared to zoledronic acid (4mg once monthly), according to analysis of four clinical studies in patients with advanced malignancies involving bone.

New primary malignancy occurred in 54/3691 (1.5%) of patients treated with Xgeva® (median exposure of 13.8 months; range: 1.0–51.7) compared to 33/3688 (0.9%) of patients treated with zoledronic acid (median exposure of 12.9 months; range: 1.0–50.8). The cumulative incidence at one year was 1.1% for denosumab and 0.6% for zoledronic acid, respectively. There was no apparent treatment-related pattern in individual cancers or cancer groupings.

A Direct Healthcare Professional Communication (DHPC) letter has been issued by Zuellig Pharma Sdn. Bhd. in agreement with NPRA to highlight this safety issue. Please refer to the DHPC for more information.