What will happen when enzalutamide (Xtandi) is approved for use in advanced prostate cancer in the disease stage prior to chemotherapy (that is if it is approved)? Already occupying this space and already approved by the FDA is both Provenge and abiraterone (Zytiga). Where will Xtandi fit in? Until we have a lot more data, [...]
There will be an abstract presented at the Upcoming (May 31- June 3) American Society of Clinical Oncologist Annual Meeting (ASCO) providing very preliminary data on a clinical trial combing Sipuleucel-T (Provenge) and enzalutamide (Xtandi) in men with metastatic castrate resistant prostate cancer (mCRPC). This rational for conducting this trial is the lack of cross [...]
Malecare announces the addition of our latest and informative teleconference about Immunotherapy and Advanced Prostate Cancer. Joining me in the conference is Dr. Nicholas J. Vogelzang, M.D., a medical oncologist with the Comprehensive Cancer Centers of Nevada (CCCN) and serves as chair and site research leader, and as medical director of the Developmental Therapeutics Committee and Member [...]
On March 4th I wrote a post which included a suggestion that combining Provenge and the clinical trial of Prostvac-VF might provide an interesting one-two punch against advanced prostate cancer. In the post I suggested that it could be interesting to have Provenge and then move immediately on to Prostvac. This was an error, I [...]
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 [...]
Confusion, confusion and more confusion, that is how I would describe the current decision making process for a man with prostate cancer that has become newly castrate resistant. Just a few years ago the decision tree was clear, castrate resistant, immediately on to chemotherapy with docetaxel. Today, in this treatment space, we have a number [...]
Since its FDA approval in 2011 FDA abiraterone (Zytiga) has supplanted docetaxel (chemotherapy), other than perhaps Provenge, as preferred first-line treatment for metastatic castrate-resistant prostate cancer. August 2012 saw the FDA approval of enzalutamide (Xtandi) for the treatment of castrate-resistant prostate cancer after chemotherapy. Researchers performed a retrospective chart review at a large medical oncology [...]
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 [...]
