Traditionally, the FDA makes its regulatory decisions based solely on demonstrated safety and provable increases in meaningful survival data. The FDA asks, Will a new treatment that is being considered for approval be able to extend our life longer than the current standard of care? They also ask if it will extend our life is [...]
According to Prostate Cancer UK The National Institute for Health and Care Excellence (NICE) has released its second draft decision on the availability of radium-223 (Xofigo). Different from the original draft this draft recommends that radium-223 be made available on the NHS for men with advanced prostate cancer that no longer responds to hormone therapy [...]
A few weeks during a devistating manufactoring problem and eventual shut down of all production many men who were relying on Xofigo (radium-233 dichloride) were put into the untenable position of missing their scheduled doses. There was mass confusion about what to do in this circumstance. Men and their doctors didn't know if they should [...]
Normally I don't write about pre-clinical things unless they are particularly interesting. You guessed it; I found a preclinical item that is interesting. According to a recent published study by Richard Pestell, M.D., Ph.D., MBA, Director of the Sidney Kimmel Cancer Center at Thomas Jefferson University the receptor CCR5, which is targeted by already approved [...]
As of January 1, 2015 there will be some significant changes in the billing and reimbursement schedule for men receiving Bayer healthcare’s radium Ra223 dichloride (Xofigo). Xofigo is FDA approved for the treatment of men with castration-resistant metastatic prostate cancer (mCRPC) who have symptomatic bone metastases and no known visceral metastatic disease. These changes result [...]
Doctors are not trained to communicate with patients. Now, with the onset of electronic medical records this problem has become worse. Many of them hardly even look their patient in the eyes; instead their faces are often buried in the computer screen and not on us. Since they don’t really know us, they stumble around, [...]
Recently there have been a number of conversations in the prostate media around the topic of treating oligometastatic prostate cancer with a curative goal. Oligometastatic prostate cancer describes the disease state where primary treatment has failed as evidenced by an increasing PSA along with scanning evidence of a limited number of lymph nodes involved in [...]
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 [...]
On December 7, 2014 the TV show 60 Minutes (CBS) aired a very interesting story (narrated by Dr. Sanjay Gupta) interview about an amazing sounding man, Dr. Patrick Soon-Shing. To describe him as a genius would be an unfair understatement. Dr. Soon-Shing is a billionaire who has already invested about $1 billion dollars of his [...]
There has been much conversation surrounding the use of intermittent androgen deprivation (IAD) as opposed to continuous androgen deprivation (CAD) in men with prostate cancer who need hormone therapy (ADT). The question that has been at issue is if either method is superior to the other. There have been studies that have concluded that they [...]
