Amgen (AMGN) said that the U.S. Food and Drug Administration has approved the supplemental Biologics License Application or sBLA for XGEVA or denosumab to expand the currently approved indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include patients with multiple myeloma.
XGEVA is a fully human monoclonal antibody that binds to and neutralizes RANK ligand (RANKL) - a protein essential for the formation, function and survival of osteoclasts, which break down bone - thereby inhibiting osteoclast-mediated bone destruction. XGEVA is currently the number one prescribed bone-targeting agent in the U.S. for the prevention of skeletal-related events in patients with bone metastases from solid tumors.
Additional regulatory applications for XGEVA for the prevention of skeletal-related events in patients with multiple myeloma are underway and have been submitted to health authorities worldwide.
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