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Amgen Presents New XGEVA™ (Denosumab) Breast Cancer Skeletal-Related Event Prevention Data at SABCS
Date:12/10/2010

udy were randomized in a one-to-one ratio to receive either 120 mg of XGEVA subcutaneously every four weeks (Q4W) or Zometa administered intravenously at a dose of 4 mg in a 15 minute infusion every four weeks adjusted for renal function as per the Zometa label instructions.

The primary endpoint of the study was to evaluate if XGEVA was non-inferior to Zometa with respect to the first, on-study SRE in patients with advanced breast cancer and bone metastases. Secondary endpoints were to evaluate if denosumab was superior to Zometa with respect to the first, on-study SRE, as well as the first-and-subsequent on-study SREs, and to assess the safety and tolerability of denosumab compared with Zometa.

Results from the primary analysis of the "136" study showed that XGEVA was superior to Zometa in delaying time to first on-study skeletal-related event in patients with breast cancer and bone metastases and that XGEVA was superior to Zometa in delaying the time to first-and-subsequent on-study SREs.

XGEVA Important Safety InformationXGEVA can cause severe hypocalcemia.  Correct pre-existing hypocalcemia prior to XGEVA treatment.  Monitor calcium levels and administer calcium, magnesium, and vitamin D as necessary.  Advise patients to contact a healthcare professional for symptoms of hypocalcemia.

Osteonecrosis of the jaw (ONJ) can occur in patients receiving XGEVA. Patients who are suspected of having or who develop ONJ while on XGEVA should receive care by a dentist or an oral surgeon.  In these patients, extensive dental surgery to treat ONJ may exacerbate the condition.  

The most common adverse reactions in patients receiving XGEVA were fatigue/asthenia, hypophosphatemia, and nausea. The most common serious adverse reaction in patients receiving XGEVA was dyspnea.  The most common adverse reactions resulting in discontinuation of XGEVA were osteonecrosis and hypocalcemia.  Please visit

SOURCE Amgen
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