FDA backs new for Amgen drug for rare bone tumors
FDA approves new use for Amgen drug Xgeva, for rare type of bone tumors seen in young adults
Biotech drugmaker Amgen Inc. said Thursday that the Food and Drug Administration has approved a new use for its bone drug Xgeva.
The company, based in Thousand Oaks, Calif., said it now can market Xgeva for treating a rare condition, giant cell tumor of bone, when surgery isn't practical.
It generally affects people aged 20 to 40. Tumors destroy bone, often causing fractures that can trigger severe pain, joint dysfunction, deformity or amputation.
The new approval is for use in adults and adolescents who've stopped growing.
Testing in patients with the condition found that one in four were helped by the injected biologic drug, but it can cause side effects including pain in multiple body parts, fatigue, nausea and damage to jawbone.
Xgeva is approved for preventing skeletal damage from solid tumors.
