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. [...]