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 [...]

Is The FDA Changing Their Criteria for Drug Approval? Maybe A Little

Is the FDA softening their stance on approving drugs using progression radiographic progression-free survival (rPFS) (how long it takes for the disease to progress based on scans) as opposed to only survival? The answer is maybe, under certain circumstances. An article in Clinical Cancer Research looked into the US Food and Drug Administration’s thinking about [...]

A Caution About Yesterday’s Post About Combining Treatments with Chemotherapy

My post to this blog that was written yesterday indicated that for certain men the early use of chemotherapy (docetaxil) could provide significant life extending benefits, especially for men with very advanced prostate cancer. For the purpose of clarification, in this case early use means in men who are still hormone responsive. Given that chemotherapy [...]

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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