Reactions 1704, p4 - 2 Jun 2018 Risk of new primary malignancies with denosumab Patients with advanced malignancies who receive denosumab (Xgeva) are at risk of developing new primary malignancies, says Amgen. In agreement with the EMA and Ireland’s Health Products Regulatory Authority, Dr Anthony Patrikios from Amgen (Executive Medical Director, UK & Ireland) issued a ’Dear Healthcare Professional’ letter advising of this new safety concern. Data from a pooled analysis of four phase III studies revealed that more patients with advanced malignancies treated with Xgeva reported a new primary malignancy (1.5%), compared with those treated with zoledronic acid (0.9%). In addition, the cumulative incidence of new primary malignancies at 1 year was higher in Xgeva-treated patients (1.1%), compared with zoledronic acid-treated patients (0.6%). Dr Patrikios also noted that "no treatment-related pattern in individual cancers or cancer groupings was apparent". Information regarding this risk of new primary malignancy will be added to the Xgeva product information. Patrikios A. Risk of New Primary Malignancy with Xgeva (denosumab): Direct Healthcare Professional Communication. Internet Document : [2 pages], 16 May 2018. Available from: URL: http://www.hpra.ie/docs/default-source/default- document-library/ 803324520 0114-9954/18/1704-0001/$14.95 Adis © 2018 Springer International Publishing AG. All rights reserved Reactions 2 Jun 2018 No. 1704
Reactions Weekly – Springer Journals
Published: Jun 2, 2018
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