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On The Horizon – Tests That Can Inform Us If A Drug Will Work Before We Take The Drug

We have become very fortunate over the last 6 years because our arsenal of potential drugs to treat advanced, metastatic prostate cancer has grown. All of our new drugs extend life and most offer palliation of pain. As I have discussed in prior posts we are still in a quandary about how best to sequence [...]

We Need Your Story To Save The CDMRP – If You Have Benefitted From Xfigo, Xtandi or Zytiga Let Me Know

Most people don't know the many advances that the Department of Defense Congressionally Directed Medical Research Program (DOD PCRP) has brought to the PROSTATE CANCER COMMUNITY.  Did you know that the program is directly responsible for funding the initial development of three of the very new drugs we have available? The DOD PCRP is directly [...]

Enzalutamide (XTANDI) Now Approved in Europe for Men With Metastatic Castration-Resistant Prostate Cancer Who Are Chemotherapy-Naïve

On Dec 2, 2014 Astellas Pharma Europe Ltd announced that the European Commission (EC) has granted a variation that amends their marketing authorization for enzalutamide (Xtandi). Based on this amended authorization Xtandi is now approved in Europe for the treatment of adult men with metastatic castration-resistant prostate cancer (mCRPC) who are asymptomatic or mildly symptomatic [...]

Xtandi Receives an FDA Review Date for Pre-Chemotherapy Use

It comes without any great surprise, but earlier in the month the FDA announced they were giving the application from Astellas and Medivation  for a priority review to extend the indication (FDA approved use) for Xtandi  (enzalutamide) capsules for the treatment of men with metastatic castration-resistant prostate cancer (mCRPC) who have not received chemotherapy.  The [...]

Sorting Out Prostate Cancers that Are Resistant to Enzalutamide (Xtandi)

Over the last several years’ prostate cancer treatment options for men with advanced prostate cancer has gone from rags to riches.  We now have multiple options for treatment and there is every indication that the number of options will continue to grow. However, we do see that not all men will respond to all treatments.  [...]

Correcting the NICE Guidance for Xtandi – It is worse for Men with Progressive Advanced Prostate Cancer

After a great deal of confusion and what turned out to be an error on my part I wish to let you know that the NICE (The U.K.’s National Institute for Health and Care Excellence) Guidance I shared on the blog on January 28, 2014 (http://advancedprostatecancer.net/?p=4360 ) about enzalutamide (Xtandi) was not accurate. In my [...]

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 [...]

NICE Changes Its Mind & Reverses Its Prior Decision on the Use of Xtandi in the UK!

Live in the UK and have advanced prostate cancer? If you do then be prepared to have economics over-ride your legitimate health concerns. The U.K.'s National Institute for Health and Care Excellence (NICE) makes no bones about what is more important, money or men’s health. NICE initially did not approve Zytiga, however when Johnson & [...]

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 [...]

A First Victory in Our Fight Against Fail First Therapy – Thanking Health Partners in Minnesota for Their Concern for Men with Advanced Prostate Cancer

Fail First Therapy or Step Therapy has been a topic I have written about in prior posts. It is my considered opinion that as it works its way into the treatment protocols for advanced prostate cancer it will have nothing but a very negative result for our health and longevity. What is Fail First Therapy [...]

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