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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 [...]

The Latest News about MDV3100 (Enzalutamide) – We Believe that Its FDA Approval is Just Around the Corner

My very dear friend and advocate supreme, Jan Manarite, from PCRI has sent me an update on MDV3100 (enzalutamide). As usual her information is important, so I thought I would pass it on today. • She points out that once the FDA approves MDV3100 (I am going to work on the assumption that it will [...]

Two Early Access Trials – 2 New sites for MDV-3100 & A New Early Access Trial for Radium-223 Chloride (Alpharedin)

There has been a lot of news in the area of early access for great drugs to treat advanced prostate cancer prior to the FDA’s approval. I have informed you about the Early Access Program for MDV-3100 in men with castrate resistant prostate cancer previously treated with a Docetaxel based chemotherapy agent. The latest news [...]

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 [...]

Some Great News for our Fellow European Survivors

Recently, it was announced that there was a submission by Astellas and Medivation to the European Regulatory Agency for Enzalutamide (MDV-3100) for the treatment of men with advanced prostate cancer post-chemotherapy The basis of the submission was the pivotal phase 3 AFFIRM study. The Marketing Authorization Application (MAA) that was made to the European Medicines [...]

Combining MDV-3100 & Provenge – A Wave of the Future?

I have heard some occasional discussion that once (that is if) enzalutamide (MDV-3100) is approved by the FDA for the treatment of men with advanced prostate cancer, it will over shadow Provenge. On the contrary, I believe that the approval of enzalutamide will actually encourage additional use of Provenge resulting in the increasing use of [...]

New Site Added for the Early/Expanded Access Trial of Enzalutamide (MDV-3100)

The Early/Expanded Access Committee has announced the addition of a new site in Atlanta, Ga for the trial of MDV-3100. According to my sources, there will be even more sites added in the near future. The role of the trial is to provide expanded Access to MDV3100 and monitor its safety in men with progressive [...]

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 [...]

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