Provenge For Low Grade Cancer
Offering Provenge for low grade cancer treatment is an option under consideration. Currently, Provenge (sipuleucel-T), the only immunotherapy for treatment of prostate cancer, has approval from the Food and Drug Administration (FDA) for use in men who have asymptomatic or minimally symptomatic advanced (metastatic) prostate cancer that has not responded to hormone therapy. In other words, the men who qualify for treatment already have advanced disease. What if Provenge were offered to “healthy” men; that is, men whose prostate cancer has not progressed to a point where the immune system is significantly compromised and the chances of recovery are not promising?
Immunotherapy is based on the concept that it stimulates the patient’s own immune system to fight the targeted disease. You could say immunotherapy is a positive course of treatment, because unlike other therapies for prostate cancer–chemotherapy, radiation therapy, cryosurgery, high intensity focused ultrasound (HIFU), and hormone therapy–no healthy cells or tissues are being destroyed and hormone production and immune system cell activity are not being suppressed.
Therefore, this means that Provenge can be viewed as a life-affirming treatment. Some experts believe Provenge for low grade cancer should be considered, because during early prostate cancer a man’s immune system is stronger and better able to take advantage of Provenge. During advanced prostate cancer, a man’s immune system is compromised, which makes success less likely.
For now, however, prescribing Provenge for low grade cancer is not possible because of FDA restrictions, but this could change. Dendreon, the maker of Provenge, is taking steps to turn the immunotherapy into a first-line therapy for prostate cancer. According to a presentation by Dendreon Corporation management at the Bank of America Merrill Lynch 2012 Health Care Conference on May 16, 2012, the drug maker “will look at moving Provenge into earlier phases of the current disease and we can probably begin a large Phase III study at some point next year.” Obviously all of this will take some time, so men should not expect to see Provenge being offered as a first-line treatment option anytime soon.
Performance of Provenge
Clinical trial results have shown that Provenge can improve overall survival by a median of 4.1 months. In a trial that included 512 men, for example, median survival for the 341 men who took Provenge survived 25.8 months compared with 21.7 months among the 171 men who took placebo.
The question is, if doctors give Provenge for low grade cancer, how will it perform? That question hopefully will be answered when new Phase III clinical trials are done.
Cost of Provenge
One downside of Provenge is cost. Partly because of the unique nature of the therapy, which requires men to have their cells customized for each of the three required treatments, the current cost of Provenge therapy is about $93,000.
What impact, if any, will possibly expanding Provenge for low grade cancer as a first-line treatment have on cost? That question also remains unanswered at this point. Apparently there are changes in the near future concerning Provenge, prostate cancer, and the men who have already been diagnosed as well as those yet to hear the words, “You have prostate cancer.”
Provenge has a bigger market than you think:
Dendreon management presents at Bank of America Merrill Lynch 2012 Health Care Conference:
Why docs are skittish about prescribing Provenge: