XGEVA pending approval for myeloma patients
Patients suffering from multiple myeloma, a cancer of the blood cells, may soon get a new treatment option if officials from the U.S. Food and Drug Administration and the European Medicines Agency expand XGEVA to treat the illness.
Amgen, the drug’s maker, is seeking to broaden XGEVA’s use after a Phase III clinical trial showed the medication, traditionally used to stall bone deterioration from solid tumors, was also effective in patients with myeloma, according to a press release.
Dr. Sean E. Harper, Amgen’s executive vice president of research and development, said that myeloma can damage a patient's bones, which until now has been successfully treated only with drugs that can cause kidney damage.
"XGEVA's unique mechanism of action may offer multiple myeloma patients a novel treatment option that is not renally cleared,” Harper said in the release. “We look forward to collaborating with regulatory authorities to make XGEVA available to this patient population with an important unmet medical need.”
Amgen based its request to alter the indications for XGEVA on information from the Phase III '482 study.
Organizations in this story
Amgen Inc. 1 Amgen Center Dr Thousand Oaks, CA 91320
U.S. Food and Drug Administration (FDA) 10903 New Hampshire Ave Silver Spring, MD 20903
European Medicines Agency 30 Churchill Place London, England E14 5EU