EC follows US example in granting new Xgeva indication

The European Commission has approved an expanded indication for Xgeva (denosumab) for the prevention of skeletal-related events in adults with advanced malignancies involving bone.

This means that the indication now covers patients with bone metastases from solid tumors and those with multiple myeloma, an extension backed by evidence from a Phase III trial that was the largest international trial ever conducted for the prevention of skeletal-related events in patients with the common hematologic cancer.

Similarly, in January of this year, the US Food and Drug Administration approved the supplemental Biologics License Application for the Amgen (Nasdaq: AMGN) drug to expand the indication for the prevention of skeletal-related events in patients with bone metastases from solid tumors to include those with multiple myeloma.