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Home Industry News Amgen’s Xgeva approved in new European multiple myeloma indication

Amgen’s Xgeva approved in new European multiple myeloma indication

4th April 2018

Amgen has announced that its cancer drug Xgeva has been approved in a new multiple myeloma indication in Europe.

The European Commission has approved an expanded indication for Xgeva, allowing it to be used for the prevention of skeletal-related events in adults with advanced malignancies involving bone, including those with bone metastases from solid tumours and individuals with multiple myeloma.

Data from the phase III '482 study, the largest international trial ever conducted for the prevention of skeletal-related events in multiple myeloma patients, has demonstrated the benefits Xgeva can provide in this application.

Amgen's drug represents the first fully human monoclonal antibody that binds to and neutralises RANK ligand, a protein essential for the formation, function and survival of the osteoclast cells involved in breaking down bone.

Dr David Reese, senior vice-president of translational sciences and oncology at Amgen, said: "We are pleased with the expanded indication for Xgeva in Europe, underscoring our dedication to advancing care for patients with multiple myeloma."

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