Xgeva (denosumab), which has already been approved by the Food and Drug Administration (FDA) for the prevention fractures in men with advanced prostate cancer that has already migrated to the bone, has been rejected by the FDA to expand the use of the drug to delay the spread of tumors in men without metastases to the bone in patients suffering from advanced prostate cancer.
The FDA has determined that the risks of taking the drug outweigh the positve effects. The FDA has asked for additional data from adequate and well-controlled trials.
The FDA decided to reject the application for the expanded use of denosumab after an advisory panel voted against it. The advisory panel expressed concern because of the rugs link to a jawbone-destroying condition (ONJ).
According to Sean Harper, executive vice president of research and development at Amgen, they intend to gather the requested information. He said, “We will work with FDA to determine any next steps.”
The FDA’s action does not impact the already approved indication of Xgeva in the prevention of fractures in men suffering from advanced prostate cancer who already have bone metastases.
Joel T. Nowak, M.A., M.S.W.
Hell. What is the difference between FDA clearance and FDA approval?
John, I have not heard of the term FDA clearance. – Joel
My physician has suggested that I begin Xgeva. I have one bone met as determined by bone scan that is unchanged in size for nine years. I am 10 years post diagnosis, on ADT monotherapy with Lupron and am not yet castrate resistant. I did receive Zometa early on for two years. I have been on fosomax for the past 5 years. I question the relative value of adding Xgeva to the mix. As I understand, the is no survival benefit although there is evidence of modest (4 month) delayed onset of bone metastasis and SREs. Adverse side affects include osteonecrosis of the jaw and hypocalemia. These side effects could make life very difficult. In addition, a recent poll of medical oncologists indicated that only 28% actually believe that this drug is superior to Zometa.
http://www.streetinsider.com/Analyst+Comments/Amgen+(AMGN)+Could+Feel+Sting+as+Xgeva+Competitor+Takes+Away+Sales+-+Analyst/7728569.html
Zometa will be available as a generic in April 2013. The cost of Xgeva is outrageous. I hope and pray for effective new medications to battle this lousy disease. However, I question the relative value of some of the drugs.The greatest benefit may be to the pharmaceutical companies and not to us prostate cancer patients. You opinion would be appreciated. I enjoy your website.
John,
The FDA has rejected the application made by Amgen Inc, to expand the use of the Xgeva to delay the spread of tumors to the bone in men with advanced prostate cancer but without bone mets. They looked at the evidence and did not feel that it warrented their approval. Some docs still recommend it at your stage, but there is a very good chance that you will have to self-pay for the drug.
Joel