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 [...]

Finding BioMarkers to Drug Sensitivity, The Next Step – ASCO Annual Meeting at ASCO GU

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 [...]

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 [...]

Preliminary Data Released for A Phase II Trial of Sipuleucel-T (Provenge) with Concurrent or Sequential Enzalutamide (Xtandi) in Metastatic Castration-Resistant Prostate Cancer (mCRPC)

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 [...]

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