One of the hot topics in the prostate cancer community is the value of detecting AR-V7 tumor cells circulating in the blood. AR-V7 tumor cells in the blood predicts response or failure of treatment with enzalutamide (Xtandi) or abiraterone (Zytiga). A recent study found that men who have AR-V7 circulating tumor cells in their blood will not [...]
Enzalutamide (Xtandi) has a new, expanded FDA label. The new label conforms with the clinical trial (TERRAIN) results that Xtandi is a superior drug to Casodex (bicalutamide) for men with metastatic castration-resistant prostate cancer (CRPC). The updated product label shows enzalutamide reduces the risk of radiographic progression or death by 40% vs. bicalutamide. Median radiographic [...]
We know that men with metastatic castration-resistant prostate cancer (mCRPC) and visceral metastases have a worse prognosis than those with non-visceral metastases. The important question we need to understand is what, of our currently available treatments, might be effective for this more aggressive and deadly type of prostate cancer? Results of the phase 3 AFFIRM [...]
CVS Health, a major retail pharmaceutical insurer and supplier has raised some consternation and concerns and it should also raise yours. Last Tuesday, CVS rolled out their 2017 formulary list that left off the some of the world’s top-selling drugs including a vital castrate resistant prostate cancer drug. The pharmacy benefits manager removed from their [...]
Speaking with men who have taken abiraterone (Zytiga, ABI) and enzalutamide (Xtandi, ENZA), at Malecare we sometimes hear reports of both cognitive and mood changes brought on by these two drugs. Evaluating these two problematic side effects researchers have confirmed our experience, both of these drugs can cause these symptoms and that more men reported [...]
We have a number of newer hormone pathway drugs now available to treat men with metastatic castrate resistant prostate cancer (mCRPC). Researchers have shown that prostate specific antigen (PSA) response can be used as a pharmaco-dynamic end-point that may help identify men with early resistance to these new drugs. They found that there is clinical [...]
The cost of Enzalutamide (Xtandi) in the United States is being challenged by Knowledge Ecology International (KEI), a public interest advocacy group. The average US wholesale price of Xtandi in 2015 was $88 per capsule. That can add up to $129,000 annual cost per man. There are significant issues related to high costs of treatment. [...]
The phase III trials for both Xtandi and Zytiga were similar. Both trials investigated men who progressed or died against placebo. Only 14% of men taking Xtandi during the trial progressed or died compared to 40% of the men in the placebo group. In the phase III trial of Zytiga 28% of the men [...]
NICE, which serves as a cost-effectiveness agency has said in a draft guidance that it supports the use of Xtandi (enzalutamide) in men whose prostate cancer has spread after the failure of first-line therapy (i.e. ADT), but for whom chemotherapy is not yet necessary. The agency found that Xtandi can delay the need for chemotherapy, [...]
Once a clinical trial has been completed, especially when the trial is positive, researchers will “data mine” the published information. The published results provide additional opportunities to evaluate the data in different ways than the trial was originally designed. This new data can be very interesting and informative, however it also needs to be considered [...]
