Denosumab effective in reducing skeletal-related events

Denosumab effective in reducing skeletal-related events

November 12, 2010

Amgen of Thousand Oaks, Calif., the maker of denosumab (Prolia) announced at a global conference last month the results of 2 integrated analyses of head-to-head pivotal phase 3 trials comparing the drug to zoledronic acid (Zometa, Novartis Pharmaceuticals), the current standard of care in the prevention of skeletal-related events in patients with advanced malignancies involving bone.

Amgen of Thousand Oaks, Calif., the maker of denosumab (Prolia) announced at a global conference last month the results of 2 integrated analyses of head-to-head pivotal phase 3 trials comparing the drug to zoledronic acid (Zometa, Novartis Pharmaceuticals), the current standard of care in the prevention of skeletal-related events (SREs) in patients with advanced malignancies involving bone.

In the separate analyses, denosumab demonstrated a clinically meaningful, consistent, and robust treatment effect across tumor types in the reduction of SREs, and it also prevented clinically relevant increases in pain, in comparison with zoledronic acid.

The analyses were presented at the 35th European Society for Medical Oncology (ESMO) Congress held in Milan, Italy, in October.

“Denosumab is superior to zoledronic acid in preventing skeletal-related events in breast cancer, prostate cancer, and other solid tumors,” Allan Lipton, MD, professor of Medicine & Oncology at the M.S. Hershey Medical Center of Penn State University, told Formulary.