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. To assist patients, Amgen has launched The Xgeva First Step Coupon Program for eligible patients who need help meeting their deductible, co-insurance, and/or co-payment requirements. Under this program, eligible patients will incur no out of pocket costs for their initial Xgeva injection and pay a maximum of $25 for subsequent injections.
Amgen has also submitted marketing applications for Xgeva in the European Union, Australia, Canada and Switzerland. For more product information visit www.xgeva.com.
Resources:
American Cancer Society: Bone Metastasis Detection, Diagnosis and Staging
http://www.cancer.org/Cancer/BoneMetastasis/DetailedGuide/bone-metastasis-diagnosis
LIVESTRONG: Bone Cancer Treatments
http://www.livestrong.com/bone-cancer-treatments/
FDA: News Release - FDA approves Xgeva to help prevent cancer-related bone injury
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm234346.htm
Amgen: Denosumab Development Fact Sheet
http://multivu.prnewswire.com/mnr/amgen/47235/docs/47235-DENOSUMAB_DEVELOPMENT_FactSheet_111710c-2.pdf
Myeloma Beacon: Xgeva Receives FDA Approval For Bone Disease In Solid Tumors, But Not Multiple Myeloma
http://www.myelomabeacon.com/news/2010/11/19/xgeva-denosumab-prolia-receives-fda-approval-for-bone-disease-in-solid-tumors-but-not-multiple-myeloma/
Cleveland Clinic Review: Denosumab: A New Therapy for Osteoporosis
http://www.clevelandclinicmeded.com/medicalpubs/pharmacy/pdf/Pharmacotherapy_XIII-1.pdf