THOUSAND OAKS, Calif. (AP) — Amgen Inc. said Monday its drug denosumab met the goals of a late-stage study in treating patients with cancer that has spread to their bones, as it performed similarly to Novartis AG’s drug Zometa. The trial compared denosumab and Zometa in the treatment of bone metastases in 1,776 advanced cancer patients. Amgen said the two drugs had similar effects in delaying the length of time until a patient’s first bone injury and subsequent bone injuries. The company said denosumab was superior in both measurements, but the difference was not statistically significant. The bone injuries included fracture, radiation or surgery to bone, or spinal cord compression. Patients in the study received either a 120 mg subcutaneous injection of denosumab once every four weeks, or a 4 mg, 15-minute infusion of Zometa every four weeks. Amgen is seeking marketing approval for denosumab as a treatment for osteoporosis, and for the prevention of bone loss in patients being treated for breast or prostate cancer. The most recent study excluded patients with breast and prostate cancer, however. Amgen reported results from another late-stage trial in July. In that study, which involved patients with breast cancer that had spread to the bone, Amgen said cancer patients who were treated with denosumab were free of skeletal injury for longer than those who took Zometa. Results from a third study have not yet been reported. A Food and Drug Administration is scheduled to review Amgen’s marketing application for denosumab on Aug. 13, and is expected to make a decision by October.
