An immune-boosting biologic therapy already used to prevent fractures in patients with bone metastases has won the
The FDA gave an expedited review to Xgeva as an orphan therapy, because its use is expected to benefit a small population of patients. Xgeva is marketed by Thousand Oaks-based
Giant cell tumor of the bone most often affects younger adults -- those between 20 and 40 years old -- and is infrequently cancerous. But it can cause unusual fractures and progressive pain, and most commonly occurs in the long bones of the body--the distal femur, proximal tibia and distal radius. In cases in which it is cancerous, it can travel to the lungs.
The FDA's approval allows Xgeva to be marketed for use in adults and adolescents whose bones have matured and whose giant cell tumors cannot be surgically removed. In a clinical trial involving 187 patients in whom giant cell tumor of the bone could be measured and could not readily be removed by surgery, 47 patients taking Xgeva had their tumor reduced in size, and growth of the tumor resumed in three of those patients.