Amgen says the US Food and Drug Administration has set a date of April 26 next year to decide whether to expand the indication on the firm's Xgeva to reduce the risk of developing bone metastases in prostate cancer sufferers.
The US biotech major notes that if approved in this expanded indication, Xgeva (denosumab) would become the first therapy licensed to prevent or delay the spread of cancer to bone. In May, it presented full Phase III data which show that the drug significantly improved median bone metastasis-free survival by 4.2 months, a risk reduction of 15%, compared to placebo.
Xgeva is already approved for the prevention of skeletal-related events in adults with bone metastases from solid tumours and is also marketed (as Prolia) for the treatment of osteoporosis. Analysts believe that sales of the RANK ligand inhibitor could be boosted by $1-$2 billion if regulators OK its use for the prevention of bone metastasis in prostate cancer patients.