Risk of new primary malignancy
A recent EU review of Xgeva has added into the product information the risk of new primary malignancy when used for the prevention of skeletal-related events in adults with advanced malignancies involving bone. A
has been sent to healthcare professionals about this risk.
In a pooled analysis of four phase III studies in patients with advanced malignancies involving bone, new primary malignancy was reported more frequently in patients treated with Xgeva (denosumab 120 mg, once a month) compared to zoledronic acid (4 mg, once a month) during the primary double-blind treatment phases of these studies.
New primary malignancy occurred in 54 (1.5%) of 3,691 patients treated with Xgeva (median exposure of 13.8 months; range: 1.0–51.7 months) and in 33 (0.9%) of 3,688 patients treated with zoledronic acid (median exposure of 12.9 months; range: 1.0–50.8 months). The cumulative incidence at 1 year was 1.1% for denosumab and 0.6% for zoledronic acid. No treatment-related pattern in individual cancers or cancer groupings were apparent.
Denosumab 120 mg (Xgeva▼) is indicated for the prevention of skeletal-related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in adults with advanced malignancies involving bone.
Denosumab 120 mg is also indicated for adults and skeletally mature adolescents with giant cell tumour of bone that is unresectable or where surgical resection is likely to result in severe morbidity (see June 2018 Drug Safety Update).
Denosumab 60 mg (Prolia) is indicated for the treatment of osteoporosis and bone loss. For full indication see Summary of Product Characteristics.
Report any suspected adverse drug reactions
The Medicines and Healthcare products Regulatory Agency continually monitors the safety of all medicines. All suspected adverse reactions associated with Xgeva▼, including new primary malignancies, should be reported to the Yellow Card Scheme.
Article citation: Drug Safety Update volume 11, issue 11; June 2018: 3.