Three out of four women diagnosed with advanced breast cancer are at high risk to develop a secondary complication known as bone metastasis or "bone mets." This occurs when cancer cells from the primary tumor relocate to the bone. In addition to breast cancer, bone metastasis occurs with lung, prostate, kidney and thyroid cancers and multiple myeloma, a blood cancer.
It's been nearly a decade since the Food and Drug Administration (FDA) has approved a targeted drug therapy for bone cancer treatment in solid tumors. The drug, Denosumab, blocks a protein that breaks down bone cells. It is currently sold by Amgen under the brand name Prolia as a treatment for osteoporosis caused by menopause.
The new use was approved based on three studies showing effectiveness in preventing fractures and skeletal problems in patients with advanced cancer. It will be marketed as Xgeva and administered using a higher dose and more frequent dosing than Prolia. Xgeva is a monoclonal antibody that targets a protein involved in cancer-related bone destruction called human RANKL. Other FDA-approved drugs for similar conditions include Zometa (zoledronic acid) and Aredia (pamidronate disodium).
Xgeva is not approved at this time for patients with multiple myeloma or other cancers of the blood. Additional clinical trials are expected to be conducted to determine whether the drug could be used for these patients in the future.
According to a news release from Amgen, more than 50 percent of cancer patients with bone metastases will experience debilitating skeletal-related events (SREs) including fractures, spinal cord compression and severe bone pain that may require surgery or radiation. Such events can profoundly disrupt a patient’s life and can cause disability and pain. Amgen puts the total economic burden of patients with bone metastases in the U.S. alone at $12.6 billion annually. The company states the use of Xgeva would result in cost offsets due to the reduced incidence of SREs and related medical costs.
Xgeva will cost $1,650 monthly.