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 blog post last Friday was among the top twenty most important ones I have written. I want to be sure that if you have taken Provenge commercially, meaning not during a clinical trial, you need to know that you might have been under-dosed and might need to be retreated. Dendreon, the company that manufactures [...]
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 [...]
More great news for men with advanced prostate cancer that is castrate resistant and who also have symptomatic bone metastases and no known visceral metastatic disease. Today, Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has approved (radium Ra 223 dichloride). Xofigo (zo-FEE-go) is the first and only alpha particle-emitting radioactive therapeutic [...]
Barvarian Nordic (BN) released some outstanding news a few days ago. According to BN they hope to complete the enrollment in their phase 3, double blind, randomized, placebo controlled, international clinical trial of their cancer vaccine, Prostvac VF. The trial known as PROSPECT is scheduled to be completed with in the next 12 months, unless [...]
Some more good news for the advanced prostate cancer community was announced today. Bayer HealthCare announced that the U.S. Food and Drug Administration (FDA) has granted priority review to their New Drug Application (NDA) filed in December 2012 for the investigational oncology compound radium-223 dichloride (radium-223). The application is under review for the treatment of [...]
On Thursday evening I had the opportunity to meet Dr. Oliver Sartor from the University of Tulane. At that time he informed me that Bayer had finally submitted the required paperwork to the FDA for formal approval of radium-233 chloride. For those of you who are not familiar with Dr. Sartor, he is both an [...]
Some mornings we just wake up to great news and today is one of those mornings. The Food and Drug Administration (FDA) has just announced that they have approved Zytiga (abiraterone acetate) for use prior to chemotherapy. - This FDA announcement is an expansion of their prior approved (April 2011) for the use of Zytiga [...]
One of the more common side effects of chemotherapy is anemia, or the lack of hemoglobin (red blood cells). Severe anemia is dangerous and will require the suspension of the use of chemotherapy as well as immediate treatment. In light of this the U.S. Food and Drug Administration (FDA) has required that Amgen Inc. developed [...]
We all manage to accumulate prescription and non-prescription medications that we no longer need. They can sit in our medicine chests accumulating dust or even be stolen and sold for illegal use. Some people just throw them away in their garbage cans and others flush them down the toilet. Al three of these solutions are [...]
