Sipuleucel-T (Provenge) has shown in clinical trials that it prolongs overall survival (OS) in asymptomatic or minimally symptomatic men with castrate resistant prostate cancer (CRPC). Unlike many other treatments for men with CRPC there are not any reliable biomarkers to show that it is working for any individual. There is also a lack of markers [...]
My blog post last Friday was among the top twenty most important ones I have written. I want to be sure that if you have taken Provenge commercially, meaning not during a clinical trial, you need to know that you might have been under-dosed and might need to be retreated. Dendreon, the company that manufactures [...]
It was announced that some dosages Provenge (sipuleucel-T) did not meet the potency release specification for CD54 upregulation, an error that might affect the ability of Provenge to kick-start the immune system. This quality control error affected less than 0.3% of Provenge’s commercial doses released since its commercial launch. Dendreon has agreed with the Food [...]
It was announced today by Dendreon Corp. that the European Commission (EC) has granted marketing authorization for Provenge in the European Union (EU) for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) castrate resistant prostate cancer in male adults in whom chemotherapy is not yet clinically indicated. This final decision by the EC follows [...]
The exciting thing about Provenge is not only the real survival advantage that it offers with minimal side effects, but that it is a proof of concept treatment that is heralding in the potential future of many other immunotherapies. Today, we have two new possible treatments in active phase 3 trials, Prostvac and Yervoy. [...]
Why does PSA continue to rise and prostate cancer disease continue to progress (new tumors develop and existing tumors continue to get bigger) when a man has an immune system treatment to go after their prostate cancer? This issue is probably the major marketing hurdle faced by Dendreon’s Provenge and based on the current statistics [...]
It was announced today that the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending that PROVENGE® (autologous peripheral blood mononuclear cells activated with PAP-GM-CSF or Sipuleucel-T) be granted marketing authorization in the European Union (EU), for the treatment of asymptomatic or minimally symptomatic metastatic (non-visceral) [...]
There was a lot of interesting and important presentations at the recent American Urological Association meeting, however the one item that will have the most impact on men with advanced prostate cancer is the new guidelines that were proposed for the treatment of men with castrate resistant prostate cancer. The guidelines were organized by creating [...]
Malecare will be holding a free teleconference this Tuesday, April 30 at 6.m. I will be speaking with Dr. James Gulley who is the Deputy Chief of the Laboratory of Tumor Immunology and Biology at the National Cancer Institute and the Director of the Clinical Trials Group. He also serves as a Senior Investigator within [...]
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 [...]
