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Cabozantinib (XL184) .......Can't come quick enough!!

Posts: 43
Joined: Mar 2012

If this is an indication of results of clinical trials on this drug, then it needs to be on the fast track for FDA approval.


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Posts: 694
Joined: Apr 2010

I agree that XL184 (Cabo) is a long way off for FDA approval (if approved). It has been in clinical trials for PCa patients since last year (http://csn.cancer.org/node/205996). Perhaps a trial might be something to look into for anyone interested in it now. While XL184 looks promising, all drugs have a range of side effects and each patient responds differently. I've heard that XL184 has had some really nasty side effects and has not been successful for many patients.

If not interested in a clinical trial for XL184 or other drugs in the medical “pipeline” of clinical trials, Xgeva, a different type of drug, is FDA approved and available now. I don't mean to sound like the nag that I am but, from the info you’ve shared on many other threads about your husband’s mPCa, Xgeva may be helpful, especially with Zytiga. You seem to have ruled out Xgeva due to co$t. (http://csn.cancer.org/node/238485#comment-1223337) If cost is the only prohibitive factor, then Amgen--the pharma manufacturer for Xgeva, has a financial assistance program that might be helpful. Here’s the link again for anyone interested: http://www.amgenassist.com/support_programs/xgeva_support.jsp

ralph.townsend1's picture
Posts: 359
Joined: Feb 2012

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.

Posts: 694
Joined: Apr 2010


The key info here that I think you may have missed is:

#1. "...rejected an application by Amgen to market denosumab (Xgeva®) AS A TX TO DELAY THE ONSET of bone metastases in men with NON-METASTATIC, castration-resistant prostate cancer (nmCRPC)." Celtic previously posted (on other threads) that her husband DOES HAVE mPCa with extensive mets--read #2.

#2. "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."

Item #2 is the current intent and reason that many knowledgeable PCa oncs continue to Rx Xgeva for men with mPCa. This is why Xgeva may be a very appropriate and important drug to consider in cases such as Celtic's husband--for the "PREVENTION of fractures and other skeletal-related events in men with metastatic prostate cancer."

Unfortunately, every PCa drug and tx has a wide range of side effects and risks, some more serious than others. I do not wish to over-promote any one drug tx (or drug combination)over another. Each patient must evaluate pros and cons and risks vs benefits to determine what level of calculated risk they are willing to take. This will be different for each patient and may be a more challenging process in advanced PCa cases. I am not a medical doctor and views expressed are lay opinions. Do your own research and always talk with your doctor about the risks vs benefits of any drug txs.

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