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 [...]

Important Additional Information About Early/Expanded Access to Enzalutamide (MDV-3100)

I now have some additional information about the Early/Expanded Access Program for Enzalutamide (MDV-3100)for men with advanced prostate cancer. Jan Manarite, who is a member of the Early Access Committee has provided the following information: From the Early/Expanded Access Committee - Now available in 10 states (see list below in this post) with additional states [...]

Breaking News- MDV-3100 Starts an Expanded Access Program in the United States

Medivation and Astellas Announce Initiation of Expanded Access Program for Enzalutamide (MDV3100) in the United States for men with metastatic prostate cancer previously treated with chemotherapy. Medivation, Inc. and Astellas Pharma Inc. today announced that they have come to an agreement with the U.S. Food and Drug Administration (FDA) which will allow them to proceed [...]

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 [...]

Combining and Sequencing the New Prostate Cancer Drugs, Can It Improve Treatment Outcomes? – On the Horizon

There is good reason for guarded optimism among men with advanced prostate cancer. Over the last 2 years we have seen some significant movement with the development of new drugs and treatments for men with advanced prostate cancer. All of these drugs have demonstrated a survival advantage in their clinical trials. Each of the agents [...]

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 [...]

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