Amgen Publishes Results of Skeletal-related Drug Study

Amgen announced the publication of results from a Phase 3 head-to-head trial that compared XGEVA to Zometa in preventing bone complications called skeletal-related events.

Amgen announced the publication of results from a Phase 3 head-to-head trial that compared XGEVA(TM) (denosumab) to Zometa(R) (zoledronic acid) in preventing bone complications called skeletal-related events in 1,901 men with prostate cancer and bone metastases. The study met its primary and secondary endpoints and demonstrated XGEVA's superiority compared to Zometa in preventing SREs.

XGEVA was approved by the U.S. FDA on Nov. 18, 2010 for the prevention of SREs in patients with bone metastases from solid tumors, including prostate cancer. XGEVA, the first and only FDA-approved RANK Ligand inhibitor, is the first new treatment for advanced cancer patients with bone metastases in nearly a decade.

"Bone metastases represent a significant risk for advanced prostate cancer patients due to the potential