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 NICE has issued a final draft guidance recommending that men with hormone-relapsed prostate cancer (castrate resistant) that has metastasized and has been treated with docetaxel (chemotherapy)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, [...]