FDA OKs agent to prevent skeletal events in patients with bone mets

December 2, 2010

The FDA has approved denosumab (Xgeva), a RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors, including prostate cancer.

The FDA has approved denosumab (Xgeva), a RANK Ligand inhibitor for the prevention of skeletal-related events (SREs) in patients with bone metastases from solid tumors, including prostate cancer.

Denosumab was approved following a 6-month priority review by the FDA, a designation reserved for drugs that offer major advances in treatment or provide a treatment where no adequate therapy exists.

"Based on the compelling science and robust clinical evidence seen with Xgeva, I expect this new option to quickly become a mainstay of cancer care and to play an important role in reducing the incidence of debilitating bone complications in patients with advanced cancer,"said David H. Henry, MD, of the University of Pennsylvania Healthcare System, Philadelphia.

The approval is based on the results of three phase III head-to-head trials that evaluated denosumab delivered every 4 weeks as a 120-mg subcutaneous injection versus zoledronic acid (Zometa) delivered every 4 weeks via a 15-minute intravenous infusion, adjusted for kidney function per the labeled instructions.

In the trials, denosumab demonstrated a clinically meaningful improvement in preventing SREs compared with zoledronic acid. Specifically, in patients with prostate or breast cancer and bone metastases, denosumab was superior to zoledronic acid in reducing the risk of SREs. Overall rates of adverse events were generally similar between the two drugs.