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Amgen hits setback in bid to expand Xgeva uses

FDA against indication to extends further use in the prevention of the spread of bone metastases in prostate cancer patients

Amgen has failed to convince an FDA advisory committee that its Xgeva product should have its indications extended to include preventing or delaying the spread of bone metastases in prostate cancer patients.

Xgeva (denosumab) is already approved to prevent skeletal events such as spinal cord compression and fractures caused by bone metastases in castration-resistant prostate cancer patients.

However, panellists voted by 12 to one that its benefits in the new indication did not outweigh the risks of therapy.

In a phase III trial filed in support of the application, Xgeva reduced the risk for bone metastases or death by 15 per cent and increased bone metastasis-free survival, or the time a patient went without developing bone metastasis, by a median of 4.2 months.

The advisory committee acknowledged these effects but said Xgeva had not shown any significant impact on survival or altered the course of the disease.

With that in mind, a 5 per cent incidence of bone disease such as osteonecrosis of the jaw tipped the risk:benefit ratio towards a recommendation against approval.

Ahead of the meeting, the FDA reviewers issued a report which questioned whether the study's findings were clinically meaningful and raised the issue about bone-related side effects.

This was particularly relevant as exposure to denosumab in the trial was longer than in the trial which supported the drug's original approval.

The news is a blow to Amgen as the additional sales afforded by the new indication could be as much as $1bn, according to analyst Jim Birchenough of BMO Capital Markets, who was quoted in a Bloomberg report.

Xgeva sales were $134m in the fourth quarter of 2011, up 31 per cent on the third quarter, and the product brought in $351m for the full year.

Another version of denosumab called Prolia and indicated for preventing fractures in women with osteoporosis added another $203m in the year. Amgen has predicted in the past that annual peak sales could top $3bn.

The FDA is scheduled to make a decision on the application by April 26.

10th February 2012

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