Expected and extraordinary news today on the new treatment front. Medivation and Astellas’ Xtandi (enzalutamide) was approved for use in men with castrate resistant prostate cancer. The new FDA approved label for Xtandi says that it is for the treatment of men with metastatic castration-resistant prostate cancer. This label is basically the same as for [...]
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 [...]
I have written a lot about how we need more data about the many new drugs we have to treat men with advanced prostate cancer. The many questions that continue to swirl around us pertain to the development of cross resistance (taking one drug causes another to not work) between these new drugs, knowing the [...]
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 [...]
Now that we have new treatments available to fight advanced, metastatic prostate cancer we need ways to decide on the best treatments given that many of the treatments occupy the same disease space. This is especially important with the soaring costs of many treatments as well as the need to not waste time by giving [...]
