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FDA Turns Down Expanded Use Of Amgen's Xgeva

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Amgen Inc. (AMGN) announced late Thursday that the Food and Drug Administration has declined to approve the company's injectable cancer drug Xgeva in the additional indication to slow the spread of cancer to the bones in men with hard-to-treat prostate cancer.

Known chemically as denosumab, Xgeva is already approved for the prevention of skeletal-related events in patients with bone metastases from solid tumors. The drug garnered sales of about $134 million in the fourth quarter of 2011, an increase of 31 percent over the third quarter, and $351 million for the full year 2011, reflecting increased segment share as well as overall segment growth.

The FDA's decision is in line with the recommendations of its advisory panel, which in February voted 12 to 1 against the expanded use of Xgeva.

In its Complete Response Letter, the FDA states that the effect on bone metastases-free survival was of insufficient magnitude to outweigh the risks, particularly osteonecrosis of the jaw, associated with Xgeva. The company has been asked to present data from an adequate and well-controlled trial demonstrating a favorable risk-benefit profile for the drug.

Amgen shares have traded in the range of $47.66 to $71.10 in the last one year. The stock closed Thursday's trading at $70.79. In the after-hours, the stock gained 0.14% to $70.89.

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