Amgen said that Xgeva is a fully human monoclonal antibody that binds to RANK Ligand, a protein essential for the formation, function and survival of osteoclasts (the cells that break down bone).
Amgen claimed that Xgeva prevents RANK Ligand from activating its receptor, RANK on the surface of osteoclasts, thereby decreasing bone destruction.
The FDA approval of Xgeva is based on the results of three pivotal, Phase 3 head-to-head trials that evaluated Xgeva delivered every four weeks as a 120 mg subcutaneous injection versus Zometa (zoledronic acid) delivered every four weeks via a 15-minute intravenous infusion, adjusted for kidney function per the labeled instructions.
In the Phase 3 trials, Xgeva demonstrated a clinically meaningful improvement in preventing SREs compared to Zometa.
Specifically, in patients with breast or prostate cancer and bone metastases, Xgeva was superior to Zometa in reducing the risk of SREs.
In patients with bone metastasis due to other solid tumors or bone lesions due to multiple myeloma, Xgeva was noninferior (trending towards superiority) to Zometa in reducing the risk of SREs.
Amgen chairman and CEO Kevin Sharer said that the approval of Xgeva illustrates what is possible when scientific innovation, commitment and investment come together to advance medicine.
Amgen has also submitted marketing applications for Xgeva in the EU, Australia, Canada and Switzerland.
In Japan, Amgen is working with its licensing partner, Daiichi-Sankyo and a marketing application was submitted in August.