XGEVA has been studied in over 6,000 patients with cancer. In clinical trials, XGEVA demonstrated a clinically meaningful improvement compared to the previous standard of care in preventing bone complications. XGEVA is also being investigated for the potential use to delay the onset of bone metastasis and disease-free survival in the adjuvant treatment of breast cancer.
XGEVA Important Safety Information
XGEVA 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
for full U.S. prescribing information.
XGEVA Regulatory Status
XGEVA has been approved in the U.S.,
, the European Union (EU),
for the prevention of SREs in patients with bone metastases from solid tumors. XGEVA is not approved to prevent SREs in patients with multiple myeloma.
XGEVA has been approved in
for the prevention of skeletal related events (pathological fracture, radiation to bone, spinal cord compression or surgery to bone) in patients with advanced malignancies involving bone. In
, Amgen is working with its licensing partner, Daiichi Sankyo Company, Limited, and denosumab is approved as RANMARK® for treatment for bone complications stemming from multiple myeloma and bone metastases from solid tumors.
Amgen has also submitted marketing applications for XGEVA in
, Gulf Cooperation Council countries,
. In addition, Amgen and GlaxoSmithKline (GSK) have a collaboration agreement for the commercialization of XGEVA in a number of countries where Amgen does not currently have a commercial presence. In these countries, marketing applications are filed by GSK.
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Forward Looking Statements
This news release contains forward-looking statements that are based on Amgen's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including statements about the planned completion of the tender offer and regulatory filings. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen's most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen's most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to Amgen's business. Unless otherwise noted, Amgen is providing this information as of
April 26, 2012
and expressly disclaims any duty to update information contained in this news release.
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