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 [...]
In my continuing reports about interesting and pertinent information released at the ASCO 2014 meeting one abstract described a phase 2 trial combining an attack on androgens in metastatic prostate cancer resistant to initial hormone therapy. This proof of concept study showed that combining Enzalutamide (Xtandi) plus abiraterone (Zytiga) drove down testosterone levels and appeared [...]
There will be an abstract presented at the Upcoming (May 31- June 3) American Society of Clinical Oncologist Annual Meeting (ASCO) providing very preliminary data on a clinical trial combing Sipuleucel-T (Provenge) and enzalutamide (Xtandi) in men with metastatic castrate resistant prostate cancer (mCRPC). This rational for conducting this trial is the lack of cross [...]
There is some really good news for those of us who live in areas where The National Institute for Health and Care Excellence (NICE) recommends drug approvals. NICE has issued a final draft guidance recommending that men with hormone-relapsed prostate cancer (castrate resistant) that has metastasized and has been treated with docetaxel (chemotherapy) should be [...]
It comes without any great surprise, but earlier in the month the FDA announced they were giving the application from Astellas and Medivation for a priority review to extend the indication (FDA approved use) for Xtandi (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. The [...]
Over the last several years’ prostate cancer treatment options for men with advanced prostate cancer has gone from rags to riches. We now have multiple options for treatment and there is every indication that the number of options will continue to grow. However, we do see that not all men will respond to all treatments. [...]
The good news is that finally Astellas and Medivation have submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking approval of XTANDI (enzalutamide) for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy. As of today XTANDI is currently only approved for [...]
Some of my posts over the last week or two have discussed the issue of the development of cross-resistance of two of our newest treatments for advanced prostate cancer. These drugs are abiraterone (Zytiga) and enzalutamide (Xtandi). Currently, both of them are approved for use after a man has failed chemotherapy with docetaxel. In addition, [...]
