FDA approves Xgeva for giant cell bone tumors
FDA Approves Xgeva for Rare, Non-Malignant Tumor
HealthDay News -- The FDA has approved denosumab (Xgeva, Amgen) to treat giant cell tumor of the bone (GCTB), a rare tumor that's most often non-cancerous, the agency announced in a press release.
The tumor usually affects adults between ages 20 and 40, although it may also develop in adolescents. GCTB typically doesn't spread, although in rare cases it can become cancerous and travel to the lungs.
As a non-cancerous tumor, GCTB destroys bone as it becomes larger, causing pain, fractures and loss of mobility. Denosumab has been approved to treat cases in which the tumor can't be surgically removed, or might lead to a severe outcome such as loss of a limb, according to the FDA.
Denosumab was first approved in 2010 to prevent fractures when cancer has spread to the bone, and received approval for the expanded indication under the FDA's expedited review program. The decision was based on results from two clinical trials involving a total of 305 adults and adolescents with recurrent, unresectable confirmed cases of GCTB.
Among 187 participants whose tumors could be measured, 47 patients had their tumors reduce in size after an average of three months. Regrowth of GCTB occurred in three patients whose tumors originally became smaller during treatment during the 20 month follow-up period.
Common side effects included joint pain, headache, nausea, fatigue, back pain and extremity pain. The most common serious side effects were osteonecrosis of the jaw and osteomyelitis.
The FDA warned that women of childbearing potential should use "highly effective" contraception while taking denosumab, since the drug can harm a fetus.
The drug was first approved in 2010 to prevent fractures when cancer has spread to the bone.