Amgen receives CHMP backing for expanded indication for Xgeva

Amgen has announced that its cancer therapy Xgeva has been recommended for European approval in an expanded indication.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has adopted a positive opinion expanding the current indication for Xgeva to cover skeletal-related events in patients with multiple myeloma.

If approved, the drug will be indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone. The application was based on data from the phase III '482 study, the largest ever international multiple myeloma trial for the prevention of skeletal-related events.

Xgeva is the first fully human monoclonal antibody that binds to and neutralises RANKL, a protein essential for the formation, function and survival of osteoclasts cells that play a key role in breaking down bone.

Dr David Reese, senior vice-president of translational sciences and oncology at Amgen, said: "The positive opinion from the CHMP to expand Xgeva's indication to cover skeletal-related events in patients with multiple myeloma is an important step forward in Amgen's commitment to improving care for multiple myeloma patients at risk for developing bone complications."

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