The US Food and Drug Administration has just announced that sipuleucel-T (Provenge) is approved for the treatment of patients with “asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.” Click here to see a copy of the FDA’s media release.
The full prescribing information giving detailed information about the clinical use of sipuleucel-T for clinicans and patients is already available on line.
Information provided by Joel Nowak, on his Advanced Prostate Cancer web site (and presumably provided to him by Dendreon), should help patients to find out whether they are eligible for treatment and how to go about seeking such treatment:
- First you need to make sure that you qualify under the approval status. This means that you must
- Have metastatic disease
- Be castrate resistant (i.e., you must have progressive disease while receiving hormone therapy or subsequent to an orchiectomy)
- Be asymptomatic or minimally symptomatic (i.e., not have any serious symptoms associated with metastatic disease, such as significant bone pain).
- If you meet these criteria your next step is to contact the Dendreon call center at 877-336-3736.
- The call center will review your status to confirm that you believe you meet the above requirements.
- If you do, they will provide contact information, including locations of the infusion centers near you.
- You should then contact the infusion center near you. (Apparently there are about 50 approved infusion centers across the country so far.)
- The intake coordinator will again review and confirm that you meet the above criteria.
- They will probably ask for your medical records and you should expect them to want to speak with your treating physician to confirm the information you have provided.
- Once these items have been resolved, they will schedule you for an appointment where your medical status will again be reviewed and you may possibly be examined by an on-site physician.
- Staff at the infusion center will review the treatment protocol with you.
- The infusion center will also confirm your insurance status and (if necessary) receive approval for the treatment.
- Once approved you will be scheduled for your first appointment to begin the actual treatment protocol.
A product-specific web site is already available at www.provenge.com (but the information on that site is very limited at present). You can also click here to see Dendreon’s media release about the approval.
Dendreon will be setting up a patient assistance program to help provide economic assistance to anyone unable to afford their insurance co-payment. You can contact their call center (877-336-3736) to learn how to access this program. As yet we have seen no announcement from Dendreon about the price of Provenge.
Prostate Cancer International and The “New” Prostate Cancer InfoLink would like to congratulate Dendreon for its focus and efficiency in making crucial information about this new product available literally within a couple of hours of the product’s approval. Many patients have been waiting for this day for a long time. It would have been tragic if they had had to wait even longer after product approval to get access to information that will help them to get treatment.