As per recent reports, it has been revealed that FDA has given green signal to Xgeva (denosumab) for the treatment of giant cell tumor of the bone (GCTB).
The FDA has publicized that they have approved Xgeva for people diagnosed with unresectable GCTB as under this condition; the tumor cannot be removed surgically. It shall however, be noted that the drug will only be given to those patients, whose bones have matured completely.
To talk about the condition, GCTB is a condition that affects people aged between 20 and 40 years. The problem is generally non-cancerous and in majority of cases, it does not spread. But when it spreads then it destroys the bone.
Some of the common symptoms of the disease spread are severe pain and fracture. Richard Pazdur, Director of the Office of Hematology and Oncology Products in FDA, was of the view, "Today's approval of Xgeva provides a needed treatment option for patients with GCTB who are not surgical candidates or who would otherwise have to undergo extensive, life-altering surgery".
Before permitting the drug, FDA experts examined two clinical trials that had 305 patients. All the patients in the clinical trials were diagnosed with GCTB that cannot be operated or was recurrent.
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