What is PROVENGE or Sipuleucel-T?
PROVENGE is the trade name of Sipuleucel-T, manufactured by Dendreon Corporation. PROVENGE is approved for the treatment of asymptomatic or minimally symptomatic metastatic castrate resistant (hormone refractory) prostate cancer – As per the US FDA. This happens to be the first therapeutic cancer vaccine approved by the US FDA. To be specific, PROVENGE is autologous cellular immunotherapy. The whole therapy is designed to culture patient’s own immune cells to activate patient’s antigen-presenting cells (APCs).
PROVENGE – FDA Approved Cellular and Gene Therapy Product
PROVENGE received its US FDA approval in April 2010. This approval was based on a randomized, double-blind, placebo-controlled, multicenter trial participated by 512 patients. The study outcomes highlighted an increased overall survival of 4.1 Months. There were two randomized phase III trials prior to this that did not result in significant outcomes. Based on the data from the IMPACT trial, FDA has determined this product to be safe and effective. More information can be found in the US FDA Q & A.
How does treatment with PROVENGE (Sipuleucel-T) work?
Cellular Immunotherapy is different and significantly advanced when compared with Chemotherapy and other medications. Unlike various treatments that are recommended in regular hospital settings, they are highly personalized. PROVENGE is a novel therapy that involves the culture and reprogramming of patient’s immune cells. A process known as “Leukapheresis”is used to extract and isolate white blood cells. These immune cells are used to develop PROVENGE at the company’s production facility. Once the modified cellular immunotherapy solution is developed, PROVENGE will be sent to the Hospital facility for infusion. It would require approximately sixty minutes for an intravenous infusion. PROVENGE is a 250 mL suspension containing a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF in Lactated Ringer’s Injection, USP. It is supplied in a sealed infusion bag, labeled for the specific recipient. Each dose of PROVENGE contains a minimum of 50 million autologous CD54+ cells activated with PAP-GM-CSF, suspended in 250 mL of Lactated Ringer’s Injection, USP. PROVENGE is shipped directly to the infusing provider in a cardboard shipping box with a special insulated polyurethane container inside. The insulated container and gel packs within the container are designed to maintain the appropriate transportation and storage temperature of PROVENGE until infusion. Refer to the PROVENGE Prescribing Information for more specific details.
Patients and caregivers can visit www.provenge.com for more relevant information. The website provides avenues to find a treatment center and healthcare professionals who can administer the drug. This is more relevant for US patients.
PROVENGE in India – Is there a possibility?
Right now there is limited information about PROVENGE India. Patients and physicians can reach out to the company representatives for better insights. More information is likely to emerge in the days to come. You can write to us at nhs@noelgenomics.com to express your interest. We are committed to provide authentic access information and assist Indian patients with advanced therapeutic solutions.
