FDA Expands Use of Amgen Drug Xgeva

The Food and Drug Administration has approved Amgen Inc.’s request to expand the indications of its drug Xgeva, a medication used to prevent fractures and other skeletal complications in patients with bone metastases from solid tumors. Under the new indications, the Thousand Oaks biotech can sell the drug for use by patients with multiple myeloma, a cancer that begins in the bone marrow. The FDA approved Xgeva, scientific name denosumab, for use in patients with multiple myeloma based on results of a study that found Xgeva to be “non-inferior” in delaying the development of skeletal-related events in multiple myeloma patients when compared with zoledronic acid, a drug commonly used to treat bone fragility in cancer patients. Overall survival was comparable between the two treatments. Xgeva already is the most commonly prescribed drug in the U.S. for preventing skeletal complications in patients with bone metastases from solid tumors, according to Amgen. Unlike other medications used to prevent bone complications in cancer patients, Xgeva is not broken down by the body through the kidneys. That makes it safe for patients who have renal conditions, Amgen executive Dr. David Reese noted in a statement. “Previously, treatment options for the prevention of complications were limited to bisphosphonates, which unlike Xgeva, are cleared by the kidneys,” said Reese, who serves as senior vice president of translational sciences and oncology. Roughly 114,000 people worldwide are diagnosed with multiple myeloma every year, according to the World Health Organization’s International Agency for Research on Cancer. A 2009 analysis by the International Myeloma Working Group found that the disease causes “osteolytic lesions” – areas of severe bone loss that can lead to pain, breakage and high blood levels of calcium – in around 90 percent of multiple myeloma patients. Amgen has applied for additional regulatory applications for the use of Xgeva in patients with multiple myeloma, the company said. Amgen stock (AMGN) rose $1.07, or less than 1 percent, on Friday to close at $180.65 on the Nasdaq.