EU expands scope of Amgen’s Xgeva

The drug’s indication now covers patients with bone metastases from solid tumors and those with the blood cancer.

In the Phase III ‘482 study, Xgeva (denosumab) showed non-inferiority to zoledronic acid in delaying the time to first on-study skeletal-related event in patients with multiple myeloma, with results showing 22.8 months versus 24.0 months, respectively.

"Many patients with multiple myeloma have bone lesions at diagnosis, which can result in serious and devastating complications, including broken bones, the need for surgery or radiation to the bone and spinal cord compression," said David Reese, senior vice president of Translational Sciences and Oncology at Amgen.

"Until now, treatment options for the prevention of bone complications were limited to bisphosphonates, which unlike Xgeva, are cleared by the kidneys and can be associated with increased renal toxicity."

Amgen says Xgeva is the first fully human monoclonal antibody that binds to and neutralises RANK ligand (RANKL) – a protein essential for the formation, function and survival of osteoclasts, cells which break down bone – thereby inhibiting osteoclast-mediated bone destruction.

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