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Amgen bone drug cleared for cancer use

Amgen has won US FDA approval of osteoporosis drug denosumab for use in patients with bone metastases from solid tumours

Amgen has won US Food and Drug Administration (FDA) approval of its marketed osteoporosis drug denosumab for the new indication of preventing skeletal-related events (SRE) in patients with bone metastases from solid tumours. The drug, which is sold under the tradename Prolia for osteoporosis, will be known as Xgeva for the oncology indication.

The new approval was based on the FDA's six-month priority review of Amgen's marketing application, which included data in more than 50 tumour types in about 5,700 patients.

Results of three phase III trials comparing Xgeva to Novartis' Zometa (zoledronic acid) found that Xgeva was more effective for reducing SREs in patients with breast or prostate cancer and bone metastases. The two drugs had similar efficacy in patients with bone metastasis due to other solid tumours or bone lesions due to multiple myeloma, and the overall rates of adverse events were similar between the two.

Xgeva has the advantage of being administered as a once-monthly subcutaneous injection, whereas Zometa is an intravenous infusion given every three to four weeks.  In addition, unlike Zometa, the Amgen drug does not require dose adjustment for changes in renal function.

Bone metastases, the spread of cancer to the bones, affect as many as 75 per cent of patients with advanced prostate, lung, and breast cancer. The cancer can weaken bones, leading to SREs such as fractures and compression of the spinal cord. Xgeva is a fully human monoclonal antibody that works by inhibiting the RANK Ligand pathway, which was indentified over a decade ago by Amgen scientists as playing a central role in cancer-induced bone destruction.

Amgen will try to lessen the financial impact of the very expensive drug on patients through its Xgeva First Step Coupon Programme, a commercial co-pay programme with no income eligibility requirement. The programme is designed for patients who have insurance but need help meeting their deductible, co-insurance, and/or co-payment requirements. Eligible patients will receive their first injection for free and will pay no more than $25 out-of-pocket for each subsequent injection, according to the company.

Marketing applications for Xgeva are pending in the European Union, Australia, Canada and Switzerland, as well as in Japan, where Amgen has licensed the product to Daiichi-Sankyo.

19th November 2010

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