FDA rejects expanded indication for denosumab, as expected


According to a Reuters report issued late last night, the U.S. Food and Drug Administration (FDA) has rejected an application by Amgen to market denosumab (Xgeva®) as a treatment to delay the onset of bone metastases in men with non-metastatic, castration-resistant prostate cancer (nmCRPC).

This will not come as a surprise to most regular readers of this blog. The FDA’s advisory committee had already voted against approval of denosumab for this indication.

A media release issued by Amgen states that:

The FDA determined that the effect on bone metastases-free survival (BMFS) was of insufficient magnitude to outweigh the risks (including osteonecrosis of the jaw) of XGEVA in the intended population, and requested data from an adequate and well-controlled trial(s) demonstrating a favorable risk-benefit profile for XGEVA that is generalizable to the U.S. population.

Whether Amgen will consider further clinical trials in an attempt to gain approval of denosumab for prevention of progression of prostate cancer in men with nmCRPC is an unanswered question at this time. The FDA’s most recent decision has no effect on the currently approved use of denosumab for the prevention of fractures and other skeletal-related events in men with metastatic prostate cancer.

One Response

  1. Here is some anecdotal evidence about denosumob’s use as Prolia, but not as Xgeva:

    (1) A friend has osteoporosis. Being female, prostate cancer is not an issue. Less than 6 months ago she considered using Prolia. Her dentist advised against it, by telling her that dentists in his country (it is not the USA but in the EU) are seeing more and more cases of ONC in their Prolia-using patients. (2) She then went to her chemist [that’s “pharmacist” for American readers], to ask for advice. He too advised against it, by telling her that Prolia is too new to assess the risks properly, that the known risks are bad enough, and that unpredicted side effects might turn up in the near future. (3) I have osteoporosis and considered using Prolia. Although I do not live in America, an American oncologist who does live there strongly advised me to use it. A thorough check showed that this oncologist had done some work for Amgen in the past. All this convinced my friend and me not to use Prolia for osteoporosis.

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