The US Food and Drug Administration (FDA) has given its clearance to Amgen's XGEVA (denosumab) to treat adult or skeletally mature patients suffering from giant cell tumor of bone (GCTB).
Approved after conducting a priority review, XGEVA becomes the first FDA-passed treatment for this rare disease that cannot be taken away through surgery or planned surgical resection may result in severe morbidity.
Amgen Research and Development executive vice president Sean Harper said, "With today's XGEVA FDA approval, Amgen can offer a much needed treatment option to patients who suffer from giant cell tumor of bone that cannot be adequately treated with surgery."
"Advances in our understanding of the underlying biology of this rare disorder have allowed Amgen to generate compelling clinical evidence to address the medical needs of patients and their healthcare providers."
During two open-label trials, XGEVA demonstrated positive results in the treatment of 187 patients with GCTB with an overall objective response rate of 25%, while safety profile data was evaluated in 304 patients.
The drug was administered every four weeks as a 120mg subcutaneous injection with additional 120mg doses on eighth and fifteenth day of the first month of therapy.
Adverse reactions found in patients were arthralgia, headache, nausea, back pain, fatigue, and pain in the extremity as well as osteonecrosis of the jaw and osteomyelitis.
