Since it FDA approval in 2004, docetaxel (a taxane based chemotherapy) has been the standard first-line chemotherapy for men with metastatic prostate cancer (mCRPC). Other than the trial of Provenge all the successful phase III trials conducted in mCRPC focused on men experiencing cancer progression after first-line docetaxel chemotherapy. The implication is that improving the [...]
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 [...]
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 [...]
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 [...]
Ra-223 (Alpharadin)is an alpha-pharmaceutical targeting bone metastases (mets) with high-energy, short-range (< 100 ?m) alpha-particles. Currently it has been submitted to the FDA for approval, which we hope will happen by August 2013. In the phase 3, double-blind, randomized, multinational ALSYMPCA study, Ra-223 significantly improved overall survival (OS) in men with castrate resistant advanced prostate [...]
Ra-223 is an investigational alpha-pharmaceutical targeting bone metastases (mets) with high-energy, short-range alpha-particles. The recently completed phase 3, double-blind, randomized, multinational ALSYMPCA study showed that Ra-223 significantly improved over all survival (OS) in CRPC men with bone mets by a median increase of 3.6 months compared with placebo (median OS: 14.9 vs 11.3 mo; P [...]
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 [...]
There are now two new, additional sites added to the Early Access Trial of the investigational treatment known as Radium-233 or Alpharadin for men with castrate resistant prostate cancer with multiple bone metastases. This post contains the most up to date and accurate information, the clinical trials.gov site is NOT currently accurate. Additionally, there are [...]
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 [...]
