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 [...]