What is the role of denosumab (Xgeva) in the treatment of hypercalcemia?

Updated: Oct 03, 2018
  • Author: Mahendra Agraharkar, MD, MBBS, FACP, FASN; Chief Editor: Vecihi Batuman, MD, FASN  more...
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Answer

The US Food and Drug Administration (FDA) approved denosumab (Xgeva) for treatment of hypercalcemia of malignancy refractory to bisphosphonate therapy in December 2014. [18] Approval was based on results from an open-label, single-arm study that enrolled patients with advanced cancer and persistent hypercalcemia after recent bisphosphonate treatment. The primary endpoint was the proportion of patients with a response, defined as albumin-corrected serum calcium (CSC) < 11.5 mg/dL (2.9 mmol/L.

The study achieved its primary endpoint with a response rate at day 10 of 63.6% in the 33 patients evaluated. The estimated median time to response (CSC < 11.5 mg/dL) was 9 days, and the median duration of response was 104 days. [19]


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