ARTICLE | Clinical News

Xgeva regulatory update

November 22, 2010 8:00 AM UTC

FDA approved an sBLA from Amgen for Xgeva denosumab to prevent skeletal-related events (SREs) in patients with bone metastases from solid tumors. Denosumab is already approved in the U.S. as Prolia to treat osteoporosis in postmenopausal women at increased risk of fracture or who have failed or are intolerant to other available osteoporosis therapy. The company said it plans to start a Phase III trial of denosumab to prevent SREs in multiple myeloma (MM) patients next year. ...