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 that after observing significant benefits in overall survival (OS) and radiographic progression free survival (PFS) ,the two co-primary endpoints of the the Xtandi pre-chemotherapy trial, the Independent Data Monitoring Committee (IDMC) for The Phase 3 PREVAIL trial of enzalutamide in metastatic prostate cancer recommends that "the study be stopped and patients [...]
Step therapy (ST) has again reared its most ugly head in our prostate cancer world, to the detriment of us, prostate cancer survivors and only to the benefit of private insurance payers. So, what is this “creeping crud,” Step Therapy (aka as Fail First Therapy)? Simply, ST is when insurance companies decide, without sound medical [...]
OncLive Peer Exchange has put out a video about the issues that most concern many of us surrounding the use of Provenge (Sipuleucel-T). The video is a 9 minute discussion with Drs. Raoul Concepcion (moderator), Leonard Gomella, Lawrence Karsh, Evan Yu and Mark Scholtz. They examine the concern that so many men with advanced prostate [...]