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, [...]

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 [...]

ASCO 2014: Combining Advanced Hormone Therapies (Zytiga & Xtandi) Shows Promise for Men with Advanced Prostate Cancer

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 [...]

Does Prior Response to Zytiga Affect Subsequent Activity of Docetaxel in Men with Metastatic Castration-Resistant Prostate Cancer (mCRPC)?

Given all the newly approved drugs available to us to treat advanced prostate cancer there now are many questions about the optimal sequencing of these drugs and whether earlier use of one causes cross-resistance to another. Recently, it was reported that chemotherapy with docetaxel is inactive in men with metastatic castrate resistant prostate cancer (mCRPC) [...]

NICE Rejects Zytiga for Men Without Chemotherapy Exposure

The National Institute for Health and Care Excellence (NICE), which is Britain’s healthcare cost-effectiveness agency, has determined that abiraterone (Zytiga) was not worth giving to men with castrate resistant metastatic prostate cancer who have yet to had chemotherapy.  Unlike the FDA in the United States which rules only on a drug’s efficacy, NICE decides if [...]

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