Amgen expects FDA decision on new indication for cancer drug by next April

Agency to decide whether to approve Xgeva for preventing prostate cancer from spreading to bones

THOUSAND OAKS, Calif. — The Food and Drug Administration will decide whether or not to approve a new usage for a cancer drug made by Amgen by next year, the drug maker said.

Amgen said the FDA would seek to take action by April 26 on its application seeking approval for Xgeva (denosumab) for preventing prostate cancer that has persisted despite castration surgery from spreading to the bones, also known as bone metastasis, one of the most common places for cancer to spread. The action date is an estimate made under the terms of the Prescription Drug User Fee Act of 2007, also known as a PDUFA date, meaning that the agency will try to complete its review of Amgen's application and make a decision by then.

Xgeva originally received approval in November 2010 for preventing skeletal injuries in patients whose cancer has spread to the bones.

The drug maker is seeking the new approval based on results of a 1,432-patient late-stage clinical trial announced in May that showed the drug reduced chances of prostate-resistant prostate cancer spreading to the bones by 15%, compared with placebo.

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