Advisory panel does NOT recommend approval of Xgeva for prevention of bone mets

According to an online report in The Washington Post earlier this afternoon, an advisory panel to the U.S. Food and Drug Administration (FDA) has voted 12 to 1 not to recommend the approval of denosumab (Xgeva®) for the prevention of bone metastasis in men with non-metastatic, castrate-resistant prostate cancer.

Will denosumab gain approval for prevention of onset of metastasis to bone?

The U.S. Food and Drug Administration (FDA) has questioned the value of denosumab (Xgeva®) as an agent capable of delaying the onset of metastatic disease to bone in men with progressive, castration-resistant prostate cancer.

Still “no sufficient evidence” to support any widespread prostate cancer prevention strategy

A new review of the available literature has concluded that, despite the fact that “prostate cancer is an ideal target for prevention,” there is in fact “no suitable evidence to recommend using any specific nutritional supplement or diet to prevent prostate cancer” at the present time.

The walnuts are back in vogue (at least with mice)

According to a media release we received yesterday, a new paper in the British Journal of Nutrition suggests that “walnuts may help to prevent prostate cancer risk.”

Dutasteride as a single agent for low-risk prostate cancer

According to data just reported in The Lancet, some men with low-volume, low-risk prostate cancer may be able to delay progression of their disease if treated only with the 5α-reductase inhibitor dutasteride (Avodart®).

Denosumab and delay of onset of bone metastasis

The full data on the use of denosumab to delay the onset of bone metastasis in men with high-risk, progressive, non-metastatic, castration-resistant prostate cancer (CRPC) were published on line yesterday in The Lancet. We originally reported the results of this trial as presented at the annual meeting of the American Urological Association (AUA) in May [...]

Is leucine blockade an important new approach to prostate cancer management?

Newly reported research from a team at the Centenary Institute in Sydney, Australia, has suggested a very different way in which it may be possible to significantly delay or manage the progression of prostate cancer.

FDA expands approval of denosumab in men with advanced prostate cancer

According to a media release issued by Amgen earlier today, the U.S. Food & Drug Administration (FDA) has approved denosumab (marketed as both Prolia® and Xgeva®) as a treatment to increase bone mass in in men with non-metastatic prostate cancer who are already being treated with androgen deprivation therapy (ADT) and who are at high [...]

Bisphosphonates in management of osteoporosis: an FDA update

Last Friday a U.S. Food & Drug Administration (FDA) advisory committee recommended (based on a 17 to 6 vote) that the labeling of bisphosphonates needed to be updated to make it clear how long patients should take these drugs to gain the greatest benefit and suffer the least risk.

But does it make a blind bit of difference?

In a newly published paper in the journal Integrative Cancer Therapies, the authors report high use of vitamins and supplements among undiagnosed men with a brother who has previously been diagnosed with prostate cancer.

Bone mineral density and other risk factors for fractures in men on ADT

Clinical guidelines issued by the National Comprehensive Cancer Network recommend that prostate cancer patients being treated with androgen deprivation therapy (ADT) — either alone or in combination with radiation therapy — should be screened for osteoporosis and treatment to prevent deterioration of bone health associated with a decline in bone mineral density.

Whole ginger extract in prostate cancer prevention and treatment

The full text of a new article on the potential of whole ginger extract (WGE) in the prevention and treatment of of prostate cancer has recently been published in the British Journal of Nutrition.

Approval of denosumab for extension of metastasis-free survival in the USA?

According to a media release from Amgen earlier today, the U.S. Food & Drug Administration (FDA) has indicated that a decision will be made by April 26, 2012 about the requested expansion of the indication for denosumab (Xgeva®) to include the prevention of bone metastases in men with non-metastatic, castration-resistant prostate cancer.

FDA publishes analysis of decision not to approve 5-ARIs for prostate cancer prevention

The “New” Prostate Cancer InfoLink is delighted to see Dr. Pazdur and colleagues from the U.S. Food & Drug Administration (FDA) present their reasoning for non-approval of the 5α-reductase inhibitors (5-ARIs) dutasteride and finasteride for prevention of prostate cancer in a new article in the New England Journal of Medicine.

5α-Reductase inhibitors and risk for high-grade prostate cancer

Yesterday the US Food & Drug Administration (FDA) updated its guidance on the use of 5α-reductase inhibitors with specific reference to the risk that use of these products may be able to induce high-grade (and therefore high-risk) prostate cancer in a small subset of men treated with these agents.

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