Amgen to discuss new Xgeva indication with FDA

Amgen has been invited to discuss its application for approval of a new indication of the drug Xgeva with the US Food and Drug Administration (FDA).

The company has been asked to participate in a meeting of the regulatory body's oncologic drugs advisory committee in order to support its submission for the drug to be used among men with castration-resistant prostate cancer at high risk of developing bone metastases.

This would represent a major milestone for Xgeva, which is currently approved in Europe and the US as a means of preventing skeletal-related events in patients with bone metastases from solid tumors.

Presently, there are no available treatments to delay or prevent the spread of cancer to bone among this patient population.

Moreover, data from phase III clinical studies has shown that Xgeva could provide a solution, as it demonstrated improved rates of progression-free survival compared to placebo.

Earlier this month, the company announced plans for its chief executive officer Kevin Sharer to step down at the end of next year, when he will be succeeded by chief operating officer Robert Bradway.