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Amgen's Xgeva cleared in US for rare bone cancer complication

Hypercalcaemia of malignancy affects around 2.7% of cancer patients

Amgen Xgeva denosumab

Amgen's bone metastasis therapy Xgeva has been approved in the US for a new indication - elevated calcium levels in the blood associated with cancer - that the firm says represents a "significant unmet medical need."

The FDA gave the go-ahead to Xgeva in hypercalcaemia of malignancy (HCM) in patients who cannot be treated using the bisphosphonate class of drugs, adding to its current use to prevent skeletal complications in patients whose cancer has spread to the bone and rare form of primary bone cancer.

HCM occurs in around 2.7% of cancer patients and is most commonly seen in those with squamous cell tumours - such as some forms of lung and head and neck cancers - and is associated with a very poor prognosis. If left untreated it can lead to renal failure, progressive mental impairment, coma and death, according to Amgen.

The number of patients affected by HCM who cannot be treated with bisphosphonates is thought to be fairly small, and the FDA has classed Xgeva as an orphan drug in this setting.

Amgen's trial supporting approval involved just 33 patients, but showed that around 64% of Xgeva-treated patients met their serum calcium target of no more than 11.5mg/dL within 10 days of starting therapy. The median time to response was nine days and the median duration of response 104 days.

Xgeva is being affected by low-cost generic bisphosphonate competition - particularly from copycat versions of Novartis' Zometa (zoledronic acid) - but despite this has proved remarkably resilient, with sales in the first nine months of the year rising 41% to $715m.

The active ingredient in Xgeva is also sold as Prolia for osteoporosis, which grew 22% to $896m in the same period.

An attempt by Amgen to expand Xgeva's use into the prevention of bone metastases in prostate cancer - which would have equated to a sizeable increase in target population - was turned down by the FDA in 2012.

Article by
Phil Taylor

9th December 2014

From: Sales



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