Amgen’s Denosumab Cleared by FDA for Second Indication

RANK-ligand inhibitor is now cleared for preventing skeletal-related events in patients with bone metastases.

FDA approved Amgen’s RANK ligand inhibitor Xgeva™ (denosumab) for the prevention of skeletal-related events in patients with bone metastases from solid tumors. Denosumab was approved in major markets including the U.S., EU, and Canada earlier this year (trademarked Prolia™) for the treatment of postmenopausal women with osteoporosis at high risk of bone fracture.

The agency’s clearance of Xgeva for the bone metastases indication followed a six-month priority review based on three pivotal head-to-head trials evaluating the drug in comparison with Zometa® (zoledronic acid). Xgeva is administered as a single subcutaneous injection every four weeks. In contrast Zometa is administered as a monthly infusion, and has to be dose-adjusted to allow for renal function.

The reviewed studies included over 5,700 patients exhibiting over 50 tumor types. Results demonstrated significant benefits of Xgeva therapy over Zometa in terms of preventing skeletal-related events among patients with breast or prostate cancer and bone metastases. Xgeva was, in addition, noninferior to Zometa in patients with bone metastases due to other solid tumors or bone lesions due to multiple myeloma. Overall rates of adverse events and serious adverse events were generally similar between the two drugs, Amgen notes.

Xgeva is currently under regulatory review in the EU, Australia, Canada, and Switzerland. Amgen has partnered with Daiichi-Sankyo for commercialization of the drug in Japan, and a marketing authorization application was submitted in August.

Amgen says estimates suggest the total economic burden of patients with bone metastases in the U.S. is in the region of $12.6 billion every year.