Amgen files Xgeva with FDA for additional indication

US biotech major Amgen (Nasdaq: AMGN) has submitted a supplemental Biologics License Application (sBLA) to the Food and Drug Administration to expand the indication for Xgeva (denosumab) to treat men with castrate-resistant prostate cancer to reduce the risk of developing bone metastases.

If approved, Xgeva would be the first therapy licensed to prevent or delay the spread of cancer to the bone. The drug has already been approved by the FDA for patients with bone metastases from solid tumors (The Pharma Letter November 19, 2010), an indication that could increase the drug’s sales potential to as much as $2.4 billion, analysts said at the time.
It also gained backing from a European Medicines advisory panel last month (TPL May 23). The drug generated sales of $42 million in its first quarter on the market. Oppenheimer analyst Bret Holley, quoted by The Associated Press, suggests that the added indication could provide annual sales of $880 million for Xgeva. Denosumab is also sold under the trade name Prolia for the treatment of osteoporosis.

The sBLA submission is based on a pivotal Phase III Study ('147) evaluating Xgeva versus placebo in 1,432 men with castrate-resistant prostate cancer (TPL May 19). Results of the '147 study demonstrate that the drug significantly prolonged bone metastasis-free survival by more than four months compared with placebo (29.5 versus 25.2 months, respectively) in men with castrate-resistant prostate cancer that had not yet spread to the bone. Bone metastasis-free survival is a composite measure of the development of bone metastases or death.