European Label Expanded for Amgen’s Xgeva

Amgen Inc.’s bone drug Xgeva has been approved by the European Commission for the prevention of skeletal complications in patients with multiple myeloma, a bone marrow cancer. The drug previously was approved in Europe for inhibiting bone issues in patients who had been treated for solid tumors. “Many patients with multiple myeloma have bone lesions at diagnosis, which can result in serious and devastating complications,” Dr. David Reese, senior vice president of translational sciences and oncology at Amgen, said in a statement. Unlike similar drugs on the market, Xgeva does not carry the risk of kidney toxicity, he added. Xgeva’s label was updated to include treatment of U.S.-based multiple myeloma patients on Jan. 5, when the Food and Drug Administration approved the change. The basis for the expansion was the results of a clinical trial that compared the efficacy of Xgeva with zoledronic acid, the first-line treatment for preventing fractures and other bone-related complications in patients with multiple myeloma. More than 1,700 patients took part in the study, which demonstrated that Xgeva was not inferior to zoledronic acid in preventing incidence of bone-related complications. Overall survival was comparable between the two drugs, according to Amgen. Xgeva sales were around $391 million last year, a 3 percent increase from the year prior, according to Securities and Exchange Commission filings. Amgen announced the label expansion on Tuesday. On Wednesday, the company’s stock (AMGN) rose $5.30, or nearly 3.2 percent, to close at $173.52 on the Nasdaq.