The FDA has approved c11 choline Injection, a Positron Emission Tomography (PET) imaging agent, for use in men to detect prostate cancer recurrences and to locate specific body sites for follow-up tissue sampling, testing and treatment. The indicated use for c11 choline injection is men with elevated prostate specific antigen (PSA) levels after earlier primary [...]
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 [...]
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 [...]
Not in the normal realm of advanced prostate cancer, but important for the prostate cancer world is the news that the FDA has approved a new screening test for prostate cancer. The currently used screening tool, the PSA has only a 55% accuracy rate and as recently run into serious trouble with The U.S. Preventive [...]
There has been an on-going debate on the advanced prostate cancer on-line support group about the issue of the efficacy of Provenge in light of the expectation of a person's increasing PSA number while getting the treatment. For many men with advanced prostate cancer this is a reason they elect to pass on this treatment [...]
Yesterday, Johnson & Johnson announced that it has asked U.S. and European Union regulators to grant broader marketing approval for its cancer pill, Zytiga which is used to treat men with castrate resistant prostate cancer. Zytiga was approved in 2011 for the treatment of advanced prostate cancer in men who have received chemotherapy and who [...]
Algeta announced that updated data from the phase III trial, ALSYMPCA, for its investigational drug Alpharadin (radium-223 dichloride). The data confirmed the overall survival of men with castration-resistant prostate cancer (CRPC) and symptomatic bone metastases using Alpharadin, compared to the interim analysis from June 2011. • Overall survival in Alpharadin arm increased by 44% • [...]
Medivation and Astellas Announce Initiation of Expanded Access Program for Enzalutamide (MDV3100) in the United States for men with metastatic prostate cancer previously treated with chemotherapy. Medivation, Inc. and Astellas Pharma Inc. today announced that they have come to an agreement with the U.S. Food and Drug Administration (FDA) which will allow them to proceed [...]
GTx Inc. announced that FDA regulators will allow it to restart the clinical trials of its investigational prostate cancer drug Capesaris for men with castrate resistant advanced prostate cancer. They anticipate that the trials of Capesaris will begin during the third quarter of 2012. The trial is designed to evaluate Capesaris as a secondary treatment [...]
Understanding and deciding on appropriate treatments for men with advanced prostate cancer can be confusing. All the treatments come with side effects and one never knows what the benefits might be for an individual. Even with good clinical trials, men with advanced prostate cancer still need to navigate a most unclear path. Provenge, ever since [...]
