Amgen, Inc. (NASDAQ:AMGN) has announced that its supplemental Biologics License Application (sBLA) for its XGEVA® (denosumab) has been approved by the U.S. Food and Drug Administration (FDA). XGEVA® will be used to increase the indications that are currently approved for the prevention of skeletal-related events among patients with bone metastases and will include patients suffering from multiple myeloma. The FDA made the approval basing on data obtained from Phase 3 ‘482 study which is the biggest global multiple myeloma clinical study to be conducted. The study enrolled a total of 1,718 patients.
In a statement, Noopur Raje, M.D., director, Center for Multiple Myeloma, Massachusetts General Hospital Cancer Center, Boston said many people always remain untreated for the prevention of bone complications and the biggest number is among renal impairment patients. “Denosumab” which is not cleaned via the kidney offers protection to patients with multiple myeloma. It is also very easy to administer and helps patients to have a novel option of treatment.
Amgen senior vice president in charge of Translational Sciences and Oncology David M. Reese, M.D said bone complications can be very devastating for many multiple myeloma patients. He added that in the past years, bisphosphonates was the only available option for prevention of bone complications. As opposed to XGEVA , bisphosphonates is cleared by the kidney. He added that they are very happy that the expanded indication for XGEVA has been approved by the FDA and is expected to offer a new option for physicians and patients and underscore the company’s commitment to offer care to multiple myeloma patients.
XGEVA is a human monoclonal antibody which attaches itself to and reduces the effect of RANK ligand (RANKL) which is a protein used in the formation, function as well as survival of osteoclasts. RANKL breaks down bone hence reducing osteoclast-mediated bone destruction. XGEVA is currently the leading prescribed bone-targeting agent in the whole United States used in the prevention of skeletal-related events in patients suffering from bone metastases that are caused by solid tumors. Further regulatory applications for the drug are underway and have been sent to health authorities globally.