A few men have asked us if the bone treatment Xgeva (Denosumab) was appropriate for them to take. This question came from men who did not have any identifiable bone metastases despite having advanced prostate cancer.
Based on guidance from the Food and Drug Administration (FDA) because they do not have bone metastases these men should not take Xgeva. Don't be confused because the FDA has approved Xgeva for men with advanced prostate cancer who do have existing bone metastases.
The FDA has determined that for men who do not have identifiable bone metastases, the risks of taking Xgeva outweigh the positive effects that the drug could offer them.
The FDA had reviewed and rejected an application for the expanded use of denosumab to include men without existing bone metastasis because of an advisory panel’s concern about the possible development of a jawbone-destroying condition (ONJ).
The FDA’s action did not impact their already approved indication of Xgeva in the prevention of fractures in men with advanced prostate cancer who have bone metastases.
Joel T. Nowak, MA, MSW wrote this Post. Joel is the CEO/Executive Director of Cancer ABCs. He is a Cancer Thriver diagnosed with five primary cancers - Thyroid, Metastatic Prostate, Renal, Melanoma, and Appendiceal Cancer a rare cancer.