FDA Approves Drug for Cancer-Related Bone Deterioration

(NIH)

Amgen Inc., a biotechnology company in Thousand Oaks, California, said the U.S. Food and Drug Administration (FDA) has approved its drug XGEVA (denosumab), for the prevention of skeletal-related events in patients with bone cancers from solid tumors. The company says FDA approved XGEVA following a 6 month priority review by the FDA, a process reserved for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.

Bone metastases, the spread of cancer to the bones, are a serious concern for patients with advanced cancer. Weakened bones due to metastases can lead to fractures and compression of the spinal cord requiring procedures like major surgery and radiation, designed to prevent or manage bone complications.

The primary goal of treatment for bone metastases is to prevent the occurrence of debilitating and costly bone complications, which can disrupt a patient’s life and cause disability, pain and hospitalization. XGEVA, says Amgen, is not indicated for the prevention of skeletal-related events in patients with multiple myeloma.

XGEVA is a human monoclonal antibody that binds to the RANK Ligand, a protein essential for the formation, function and survival of  the cells that break down bone, called osteoclasts. XGEVA prevents RANK Ligand from activating its receptor, RANK on the surface of osteoclasts, thereby decreasing bone destruction.

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