Direct healthcare professional communication on the risk of occurrence of new primary malignancies associated with the use of XGEVA (denosumab)
Amgen Europe B.V., in agreement with the Agency for Medicinal Products and Medical Devices (HALMED) and the European Medicines Agency (EMA), have informed healthcare professionals on the risk of occurrence of new primary malignancies associated with the use of XGEVA (denosumab). New primary malignancies were reported more frequently in clinical studies in patients with advanced malignancies treated with XGEVA (denosumab) compared to zoledronic acid.
The cumulative incidence of new primary malignancies at one year was 1.1% for denosumab treated patients compared to 0.6% for zoledronic acid treated patients. No treatment-related pattern in individual cancers or cancer groupings was apparent.
The direct healthcare professional communication is available here.
Healthcare professionals are being reminded that they should report any suspected adverse reaction, as well as quality defect to HALMED. Patients who have developed an adverse reaction to a medicinal product may also report it directly to HALMED. HALMED recommends that patients contact their doctor or pharmacist regarding any adverse reaction they notice.