Xgeva® (denosumab): Risk of New Primary Malignancy

User Rating: 0 / 5

Star InactiveStar InactiveStar InactiveStar InactiveStar Inactive
 

 

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.

 

National Pharmaceutical Regulatory Agency (NPRA)
Lot 36, Jalan Universiti, 46200 Petaling Jaya, Selangor, Malaysia.
  • Email: npra@npra.gov.my
  • Phone: +603-7883 5400
  • Fax: +603-7956 2924, +603-7956 7075

DISCLAIMER

The Government of Malaysia and the National Pharmaceutical Regulatory Agency are not responsible for any loss or damage caused by the usage of any information obtained from this website.

Mobile Web :

Newsletter Subsription

Site Last Modified

  • Last Modified: Monday 10 December 2018, 14:32:16.
© Copyright 2018 . All Rights Reserved National Pharmaceutical Regulatory Agency NPRA

MOH Pharmacy Staff