Somehow I have been negligent and not let people know that I have written and posted a major update of my “Guide to Advanced Prostate Cancer.” As in the past, it is available as a free download from the Malecare web site. Helping me to update the book was prostate cancer survivor Craig Pynn and [...]
Malecare was actively involved, along with its partners, in setting up the early access trial for enzalutamide (Xtandi). The trial was conducted after the final Phase 3 AFFIRM trial that was eventually used to obtain FDA approval had been stopped, but before the FDA and received the final submission of the data. Given the significant [...]
Men with metastatic castration-resistant prostate cancer (mCRPC) in Québec, Canada now have access to Zytiga (abiraterone acetate) prior to having chemotherapy. Effective February 3, 2014, the province has added ZYTIGA to the public drug formulary for the treatment of mCRPC in men who are asymptomatic or mildly symptomatic after failure of androgen deprivation therapy (ADT). [...]
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 [...]
I want to share that I am hopeful that we have made progress with Bayer Healthcare and the issues I have written about surrounding the newly approved treatment for men with castrate resistant prostate cancer, Xofigo. I have shared that they failed to support the early access trials because of what they claimed were supply [...]
The committee to start the early access clinical trials for drugs and treatments for men with advanced prostate cancer has been very hard at work. Based on the leadership and tenacity of Jan Manarite of the Prostate Cancer Research Institute (PCRI) we have managed to encourage, beg and cajole a number of pharmaceutical (pharma) companies [...]
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 [...]
The Early/Expanded Access Committee has been continuing to work on getting additional sites open for men with advanced prostate cancer to get access to the yet unapproved drug Radium-233 Chloride (Alapharadin). Due to the hard work of this committee there are now sites in seven different states. In order to qualify for this treatment you [...]
The Early Access Committee on which Malecare sits has been successful in adding an additional site in Long Island, New York to the Early Access Trial of Radium-233 Chloride (Alpharedin) for men with advanced prostate cancer who are castrate resistant and have at least two (2) bone metastases. If you are interested in this trial [...]
The Early Access Committee Announces an Additional Site for Radium-223 Chloride (Alpharadin) in Castration-Resistant (Hormone-Refractory) Prostate Cancer Patients With Bone Metastases We have been able to get Bayer to open another early access site for Alpharedin. This additional site is in Boston, Ma. In addition to this new site there are still three other sites. [...]
