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Paul Edwards posted a topic in Articles on other sitesThanks to Chuck Maack for alerting us to this. A collaboration between leading US and British Cancer Centres has been described as a landmark study. Click on this link to read a report of the study. Chuck's comment This appears to be terrific news. The problem now is whether or not the researchers get fast-track funding to continue their research to determine which medications currently are correct for which genomic defects, and what medications are available and might be used singularly or in combination with other medications to go after the other genomic defects. Then…and we don’t know when…we are going to need government approval for coverage for the gene testing that will permit Medicare to cover that expense..... And (another) then, we will need FDA approval (in Australia, TGA approval) for those medications not yet developed/determined or approved for prostate cancer, but now necessary, as well as may need combining with other medications. So, it looks like now it will be a matter of time and how fast-track they continue this research.
Orteronel (TAK-700) is an androgen synthesis inhibitor. It selectively inhibits the enzyme CYP17A1.. A paper presented yesterday at the American Society for Clinical Oncology (ASCO) meeting reported the results of a second large Phase III clinical trial of Orteronel + Prednisone in the treatment of chemotherapy-naive, metastatic, castration-resistant prostate cancer. In the trial, whilst treatment with Orteronel + Prednisone was shown to delay the onset of radiographic progression, there was no overall survival benefit. Orteronel + Prednisone was also associated with a number of significant side effects compared to placebo + prednisone; 30% of patients on the Orteronel + Prednisone arm of the trial discontinued due to adverse side effects. A previous Phase III clinical trial of Ortoronel + Prednisone for the treatment of men with progressive, metastatic, castration-resistant prostate cancer who had been previously treated with at least one cycle of docetaxel-based chemotherapy also showed no overall survival benefit. The New Prostate Cancer Infolink commented: "This is clearly a second major setback for the potential of Orteronel as a potential treatment for prostate cancer, and it is hard to see that the developers will pursue the potential of this product for much longer.” Given that other drugs recently approved by the American Food and Drug Administration (FDA) such as Zytiga and Xtandi have demonstrated an overall survival benefit, it is unlikely that Orteronel would receive FDA approval on the current evidence.