FDA approves Xgeva (denosumab) for oncology indication

Amgen's ($AMGN) denosumab--already approved under the brand name Prolia for osteoporosis--has won FDA approval for the prevention of skeletal-related events in patients with bone metastases from solid tumors. When cancer spreads to the bones it can lead to fractures and compression of the spinal cord, which can be debliltating for cancer patients.

With the additonal indication, analysts project that denosumab could bring in $2.4 billion in sales by 2015. And another half billion could be coming Amgen's way if the company can prove Xgeva prevents cancer from spreading to the bone, according to Citigroup analyst Yaron Werber. Results for that indication are expected before the end of 2010. Amgen's revenue has been flat over the last four years; Xgeva could be just the shot in the arm the aging biotech needs to revive sales. "This is a big, important step for the company, launching a new product which will help put the company back on a growth trajectory," Werber told Bloomberg.

"Based on the compelling science and robust clinical evidence seen with Xgeva, I expect this new option to quickly become a mainstay of cancer care and to play an important role in reducing the incidence of debilitating bone complications in patients with advanced cancer," said University of Pennsylvania Healthcare System's David Henry, M.D., in a statement.

- check out Amgen's release
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