Xtandi Today & Tomorrow

Medivation, the pharmaceutical company that owns Xtandi (formerly known as MDV-3100), the new androgen receptor antagonist to treat castrate resistant advanced prostate cancer has a number of active clinical trials, despite the fact that it has already been approved for use. The current FDA approval is specific; it has been approved for men who are [...]

Four New Sites Added to the MDV3100 (Enzalutamide) Early Access Trial

The Early/Expanded Access Committee has informed me that four additional sites have been added to the trial so there are now 23 States that have an expanded access trial of MDV3100 available to men with advanced prostate cancer. The trial is designed to monitor the safety of the drug in men with progressive castration-resistant advanced [...]

Failing Zytiga – Some Requirements to Access the MDV-3100 Early Access Trial

Many of us in the United States with advanced prostate cancer who have failed Zytiga are looking to enter the Early Access MDV-3100 Clinical Trial. However, you need to be aware that there are some requirements you will need to meet prior to starting MDV-3100. You will need to wait 30 days after stopping Zytiga [...]

From ASCO: Enzalutamide (MDV-3100) Data Relating to Quality of Life Measures and Extension of Time to First Skeletal-Related Event

The American Society of Clinical Oncologists (ASCO) has started their annual conference in Chicago. I am anticipating a number of interesting and important abstracts that will be directly relevant to those of us with advanced prostate cancer. Among the first release of information comes an announcement from Medivation Inc. and Astellas Pharma Inc. who have [...]

Zytiga in High Doses and Zytiga Combined with MDV3100 Increase the Length of Response Time In Men with Advanced Prostate Cancer

According to recent trials led by The Institute of Cancer Research (ICR) (UK) and The Royal Marsden (UK) combining Zytiga (abiraterone acetate) with the yet FDA unapproved investigational drug MDV3100 could increase the number of men, with advanced prostate cancer, who respond to treatment as well as the length of time they benefit. A new [...]

Data From Phase 3 AFFIRM Trial of MDV3100 in Advanced Prostate Cancer

We are about to finally get a more formal presentation of the great news we have all been waiting to hear. Medivation Inc. and Astellas Pharma Inc. announced that data from their Phase 3 AFFIRM trial, evaluating MDV3100 in men with advanced prostate cancer, will be highlighted in a late-breaking oral presentation at the upcoming [...]

On The Horizon – MDV3100 in Men With Advanced Prostate Cancer Study Will Be Stopped Early and MDV3100 Offered to All Participants

It was announced yesterday that the Independent Data Monitoring Committee (IDMC) has informed the the pharmaceuticals, Medivation and Astellas of positive results from a planned interim analysis of the Phase 3 AFFIRM trial of MDV3100 in men with advanced prostate cancer previously treated with chemotherapy. The monitoring committee found that MDV3100, the first androgen receptor [...]

Attacking Androgen Receptor Signaling In Castrate Resistant Prostate Cancer

Advanced prostate cancer eventually progresses and becomes castration resistant (CRPC) despite the fact that it is exquisitely sensitivity to androgen deprivation therapy. There has been recent evidence that prostate cancer progression at the CRPC stage is still mediated by androgen receptor signaling, so it seems that subsequent androgen receptor targeting may further contribute to disease [...]

On The Horizon – Some More Information & An Update On MDV3100

Many of us are aware of the newly approved drug Zytiga (abiraterone). It had demonstrated a survival advantage for men who are castrate resistant and failed chemotherapy. Zytiga was approved by the FDA in April and many of us with advanced prostate cancer have been taking advantage of the drug. You can learn more about [...]

Announcing A Phase 2 Clinical Trial of MDV3100 in Hormone-Naive Prostate Cancer Patients

For our European readers who have not yet started, but are getting ready to start hormone deprivation therapy (ADT), there is a new clinical trial you should consider. This trial is evaluating MDV3100 monotherapy as the first hormonal treatment of patients with prostate cancer. Enrolled men would not have had any previous hormonal therapies for [...]