Enzalutamide (XTANDI) Now Approved in Europe for Men With Metastatic Castration-Resistant Prostate Cancer Who Are Chemotherapy-Naïve

On Dec 2, 2014 Astellas Pharma Europe Ltd announced that the European Commission (EC) has granted a variation that amends their marketing authorization for enzalutamide (Xtandi). Based on this amended authorization Xtandi is now approved in Europe for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic [...]

Europe Awaits Xtandi – A Positive CHMP Opinion on the Clearance of Enzalutamide In the Pre-Chemotherapy Stage of Prostate Cancer

Some good news for my European brothers, the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) has adapted a positive opinion in support of the label expansion of enzalutamide (XTANDI) to include the treatment of men with metastatic castrate resistant prostate cancer (MCRPC) who are asymptomatic or mildly symptomatic after the failure [...]

The Well Reviewed Guide to Advanced Prostate Cancer (A Survivor Perspective) Has Been Updated and is Now Available for a free Download

Somehow I have been negligent and not let people know that I have written and posted a major update of my “Guide to Advanced Prostate Cancer.” As in the past, it is available as a free download from the Malecare web site. Helping me to update the book was prostate cancer survivor Craig Pynn and [...]

Xtandi (enzaludamide) Receives FDA Approval in the Pre-Chemo Stage of Prostate Cancer Treatment

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 [...]

Clinical Benefit of Docetaxel or Enzalutamide After Progression on First-Line Abiraterone and Prednisone in Men with Metastatic Castration Resistant Prostate Cancer (mCRPC) *

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 [...]

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