Xgeva for giant cell tumor of bone – pro
In June 2013, the US Food and Drug Administration (FDA) announced that it was expanding the approved use of denosumab (Xgeva, Amgen) to include the treatment of adults and adolescents with giant cell tumor of bone (GCTB). It is, therefore, medically necessary. The approval was based on a study that appeared in Lancet 2013. It was a pahse I study, pahse I study having been previously publihsed also in Lancet. 96% of the patients benefitted, some remarkably, with mild of minmal toxicity. These results, in addition t the fact that no other treatment is currently available for the young patients who usually suffer from this disease, led to a swift approval.
Prescribing Information, Xgeva 2014
David Thomas et al, Denosumab in patients with giant-cell tumour of bone: an open-label, phase 2 study
The Lancet Oncology, Volume 11, Issue 3, Pages 275 – 280
Sant Chawla et al,Safety and efficacy of denosumab for adults and skeletally mature adolescents with giant cell tumour of bone: interim analysis of an open-label, parallel-group, phase 2 study,
The Lancet Oncology, Volume 14, Issue 9, Pages 901 – 908, August 2013