THOUSAND OAKS (dpa-AFX) - Amgen Inc. (AMGN) said Thursday that the U.S. Food and Drug Administration has approved a new indication for XGEVA (denosumab) as the first and only treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.
XGEVA was approved following a priority review by the FDA, a designation reserved for drugs that offer major advances in treatment, or provide a treatment where no adequate therapy exists.
Giant cell tumor of bone, or GCTB, typically affects individuals between the ages of 20 to 40. The disease is characterized by a bone destructive tumor that often results in fractures. It is estimated that there are about 300-800 new cases of GCTB annually in the U.S.
The approval of XGEVA is based on positive results from two open-label trials that enrolled patients with GCTB that was either recurrent, unresectable, or for which planned surgery was likely to result in severe morbidity.
The overall objective response rate of the 187 patients evaluated was 25 percent. The estimated median time to response was three months. In the 47 patients with an objective response, 51 percent had a duration of response lasting at least eight months. Three patients experienced disease progression following an objective response.
The safety profile of XGEVA in patients with GCTB was similar to that reported in studies of patients with bone metastases, and also appeared to be similar in skeletally mature adolescents and adults.
The most common adverse reactions were arthralgia, headache, nausea, back pain, fatigue, and pain in the extremity. The most common serious adverse reactions were osteonecrosis of the jaw and osteomyelitis.
XGEVA was approved by the FDA for the prevention of skeletal-related events in patients with bone metastases from solid tumors in 2010.
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