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 [...]
In clinical trials Enzalutamide (Xtandi) significantly increased the overall survival and radiographic progression-free survival of men when compared with placebo. The trial, called PREVAIL evaluated men who were asymptomatic and minimally symptomatic, chemotherapy-naive with metastatic castration-resistant prostate cancer. The researchers expanded the data analysis and evaluated the effect of Xtandi on the men’s health-related quality [...]
Analysis of the PREVAIL Trial showed that Enzalutamide (Xtandi) significantly increased overall survival and radiographic progression-free survival compared with placebo in men with prostate cancer who were asymptomatic and minimally symptomatic, chemotherapy-naive and who had metastatic castration-resistant prostate cancer (mCRPC). Now, an additional analysis of the data has shown the effect enzalutamide also has on [...]
Abiraterone acetate (AA) or Zytiga has demonstrated a survival benefit in the pre-chemotherapy setting for men with advanced prostate cancer that has become castrate resistant (mCRPC). As a result it is in widespread clinical use in the United States prior to the use of chemotherapy with docetaxel. Since its FDA approval post chemotherapy there has [...]
British Men Who Have Had Abiraterone Will Not Get Enzalutamide Despite Its Life Extending Ability Our brothers in England hit a major snag last week as NHS placed a burdensome restriction on the use of enzalutamide (Xtandi) for men with advanced prostate cancer who have already had abiraterone (Zytiga). Because of this ridiculous decision thousands [...]
In yesterday's post I wrote about the possibility of looking for the presence of the splice variant ARV7 to determine if you would be resistant to enzalutamide (Xtandi). Today I am going to expand on this issue and discuss an additional study that demonstrated that the presence of ARV7 in circulating tumor cells not only [...]
Abiraterone Acetate (Zytiga) and enzalutamide (Xtandi) are the newest generation hormonal agents. They both have demonstrated a survival advantage in men with castrate resistant prostate cancer (CRPC) who have already been treated with docetaxel (chemotherapy). Unfortunately all men who are responsive to both of these drugs eventually become resistant. Some men are subject to early [...]
What will happen when enzalutamide (Xtandi) is approved for use in advanced prostate cancer in the disease stage prior to chemotherapy (that is if it is approved)? Already occupying this space and already approved by the FDA is both Provenge and abiraterone (Zytiga). Where will Xtandi fit in? Until we have a lot more data, [...]
Malecare was actively involved, along with its partners, in setting up the early access trial for enzalutamide (Xtandi). The trial was conducted after the final Phase 3 AFFIRM trial that was eventually used to obtain FDA approval had been stopped, but before the FDA and received the final submission of the data. Given the significant [...]
The FDA approved Abiraterone acetate (Zytiga) plus prednisone because it demonstrated a survival benefit for men with metastatic castrate resistant prostate cancer (mCRPC) in the pre-chemotherapy setting. Given the newness of the approval of Zytiga in this disease stage there is a lack of data on how Zytiga affects the efficacy of enzalutamide (Xtandi) or [...]
