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*After the Failure of Docetaxel Is There A Best Sequence For Other Treatments?: Results of an Italian Multicenter Study

As we all know there are now a number of new drugs available to treat castrate resistant metastatic prostate cancer (mCRPC). The availability of these new drugs (abiraterone acetate aka Zytiga, cabazitaxel aka Jevtana, and enzalutamide aka Xtandi) for use in men with mCRPC after the failure of chemotherapy (with docetaxel) has opened a number [...]

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 [...]

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 [...]

British Men Who Have Had Abiraterone Will Not Get Enzalutamide Despite Its Life Extending Abilities

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 [...]

Predicting Resistance to Enzalutamide and Abiraterone in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC).*

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 [...]

PSA Decline is a Potential Biomarker for Identifying Early Resistance to Zytiga and Xtandi In Men Who are Post Chemotherapy*

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 [...]

Looking Forward Towards the Future – Zytiga or Xtandi First After Provenge

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, [...]

Results of the Earl Access Trial of Enzalutamide Leading to the FDA Approval

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 [...]

An Analysis of the Clinical Benefit of Chemotherapy & Xtandi Post Zytiga in Men with Metastatic Castration Resistant Prostate Cancer

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 [...]

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