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 & [...]
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 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 [...]
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 [...]
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 [...]
The makers of Enzalutamide (Xtandi), Astellas Pharma US, Inc and Medivation, Inc have begun a Phase 4 clinical trial known as PLATO. The study is designed to evaluate the efficacy and safety of continued treatment with enzalutamide (Xtandi) plus abiraterone acetate (Zytiga) and prednisone as compared to treatment with Zytiga and prednisone alone in men [...]
Castate resistant metastatic prostate cancer (mRPC) withvisceral disease (tumors involving the internal organs of the body, specifically those within the chest (as the heart or lungs) or abdomen (as the liver, pancreas or intestines) is a negative prognostic factor. In many cases clinical trials of new investigational drugs rule out men with visceral disease from [...]
It was announced today that after observing significant benefits in overall survival (OS) and radiographic progression free survival (PFS) ,the two co-primary endpoints of the the Xtandi pre-chemotherapy trial, the Independent Data Monitoring Committee (IDMC) for The Phase 3 PREVAIL trial of enzalutamide in metastatic prostate cancer recommends that "the study be stopped and patients [...]
Step therapy (ST) has again reared its most ugly head in our prostate cancer world, to the detriment of us, prostate cancer survivors and only to the benefit of private insurance payers. So, what is this “creeping crud,” Step Therapy (aka as Fail First Therapy)? Simply, ST is when insurance companies decide, without sound medical [...]
At the 2013 European Cancer Congress in Amsterdam Dr. Howard Scher from Sloan Kettering Hospital reported that a panel of biomarkers could identify men with metastatic, castration-resistant prostate cancer (mCRPC) who were responding well or less well to treatment with Zytiga + prednisone (abiraterone + prednisone). Dr. Scher provided data in his presentation to support [...]
