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 [...]
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 [...]
The U.S. Food and Drug Administration today, August 31, 2012 approved Xtandi® (MDV3100) (enzalutamide) capsules to treat men with late-stage (metastatic) castration-resistant prostate cancer that has spread or recurred, even with medical or surgical therapy to minimize testosterone. Approved for prostate cancer patients previously treated with chemotherapy, Xtandi was reviewed under the FDA’s priority review [...]
On Wednesday, Johnson & Johnson said that the FDA will conduct a fast review of Zytiga as a treatment for men with advanced prostate cancer who have not received chemotherapy. The Food and Drug Administration has agreed to conduct a six-month review of Zytiga which should be completed in mid-December, 2012. According to representatives from [...]
My very dear friend and advocate supreme, Jan Manarite, from PCRI has sent me an update on MDV3100 (enzalutamide). As usual her information is important, so I thought I would pass it on today. • She points out that once the FDA approves MDV3100 (I am going to work on the assumption that it will [...]
Recently, it was announced that there was a submission by Astellas and Medivation to the European Regulatory Agency for Enzalutamide (MDV-3100) for the treatment of men with advanced prostate cancer post-chemotherapy The basis of the submission was the pivotal phase 3 AFFIRM study. The Marketing Authorization Application (MAA) that was made to the European Medicines [...]
