Amgen to apply for new indication of Xgeva

Amgen has announced plans to apply for approval of its drug Xgeva in a new indication in the US.

The pharmaceutical company has targeted a Prescription Drug User Fee Act action date of April 26th 2012 for a supplemental biologics license application for the compound as a means of preventing bone metastases among castrate-resistant prostate cancer.

Xgeva is not currently approved for this specification in any territories, with European and US regulators having backed it as a therapy for skeletal-related events in patients with bone metastases from solid tumours.

Should the US Food and Drug Administration approve the therapy in this indication, it would make Xgeva the first product licensed to prevent or delay the spread of cancer to bone.

This would be an important development, as bone is typically one of the most common areas for cancer to spread.

Next month, the company will be attending the American Society for Bone and Mineral Research annual meeting, where it will present new data demonstrating the efficacy of its osteoporosis treatment Prolia.