An Early Peek At the Phase III PREVAIL Trial of Enzalutamide (Xtandi) Results – Good For Prostate Cancer

An important update from the phase III PREVAIL study (Xtandi in the pre-chemotherapy stage) was released thsi evening (actually yesterday evening) in advance of a formal presentation this Thursday at ASCO GU. The news is good, no the news is great. Last November the trial of Xtandi in men with metastatic castrate resistant prostate cancer [...]

A Statistical Nightmare – Comparing the Efficacy of Zytiga & Xtandi In the Pre-Chemo Setting

Based on the assumption that Enzalutamide (Xtandi) is approved for use in men with castrate resistant metastatic prostate cancer (advanced prostate cancer or mCRPC) who have not had prior chemotherapy, pretty much a foregone conclusion based on the extraordinary phase III Prevail Trial results, including a statistically significant survival advantage of 2.2 months with a [...]

Canada Gets the Nod for the Use of Xtandi

Some good news for my neighbors immediately to my north. Enzalutamide (Xtandi) has received Health Canada's approval for the treatment of metastatic castration-resistand advanced prostate cancer in the post chemotherapy phase. This means that any man with castrate resistant prostate cancer, once they have received taxotere can now get Xtandi. Xtandi works by being a [...]

Enzalutamide (Xtandi) Monotherapy Highly Active in Men Who Have Not Had Prior ADT

Enzalutamide (Xtandi) monotherapy induced striking declines in prostate-specific antigen (PSA) in a majority of patients with hormone-naive prostate cancer in a phase II trial, and this oral agent appears to have little effect on bone mineral density. If these findings are confirmed in a phase III trial, then enzalutamide may be an alternative to androgen [...]

Efficacy and Safety of Enzalutamide (Xtandi) Monotherapy in Hormone-Naive Prostate Cancer (HNPC)

Xtandi is often referred to as a “super bicalutamide (Casodex).” Casodex functions as a androgen blockade, which deters testosterone from being able to interact with the prostate cancer cell and feed the growth of the cancer. There are some oncologists in the United States and the standard hormone treatment in Europe often utilizes Casodex as [...]

XTANDI (Enzalutamide) Has Been Authorized in the European Union (EU) for Advanced Prostate Cancer

The great news for for our brothers in Europe is that Xtandi (Enzalutamide) has been approved for use in the European Union (EU) for the treatment of men with metastatic castration-resistant prostate cancer whose disease has progressed on or after chemotherapy (docetaxel). Following the regulatory review process by the European Medicines Agency (EMA) and a [...]

Sequencing Xtandi – Possibly the ADT of the Future? An Interview with Dr. Bertrand Tombal

There was a recent interview in the Pharma Strategy Blog with Dr. Bertrand Tombal , an academic urologist in Belgium. Dr. Tomal discussed several of the new advances in the treatment od advanced prostate cancer with an emphasis on the potential future of Enzalutamide (Xtandi). Like bicalutamide (Casodex), Xtandi works by blocking (inhibiting) testosterone from [...]

Survival Advantage of Abiraterone Acetate (Zytiga) in Men with Castrate Resistant Metastatic Advanced Prostate Cancer

We all know that abiraterone acetate (Zytiga) plus prednisone provides a survival advantage for men with castrate resistant advanced prostate cancer (mCRPC) who have had prior treatment with a taxane based chemotherapy. New information has shown that abiraterone acetate offers a somewhat longer overall survival benefit than the data originally presented when the trial halted [...]

So Much Has Happened While I was Away – News About Advanced Prostate Cancer

The summer is coming to a close and I am back, ready to again take on the world. I had the fantastic opportunity of spending almost two weeks in Alaska, a land that is so different from the lower 48. I have to say that I have a new found respect for those individuals who [...]

Early Access Program Needs Your Help – Share Your Experiences to Insure A Continuing Program

Dr. Moyad has been the driving force behind getting the Early Access Program for drugs to treat advanced prostate cancer.  Along with the Early Access Committee he has arranged for an early access (before the formal approval from the FDA) for both Zytiga and now MDV3100.  (you can read about the programs including how to [...]