Extension of indication includes the avoidance of skeletal-related events in grown-ups with late-stage malignancies involving the bone
On 22 February 2018, the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending towards a change in the marketing authorisation for denosumab (licensee: Amgen Europe BV).
The following extension of the label was adopted by the CHMP:
- Prevention of skeletal-related events in adults with advanced malignancies involving bone (e.g. pathological fracture, radiation to the bone, spinal cord compression, or surgery to the bone).
Previously, denosumab was only indicated for the prevention of skeletal-related events in adults with bone metastases from solid tumours.