Provenge ( Sipuleucel-T ) is an autologous cellular immunotherapy designed to stimulate a patients own immune system against cancer. Provenge is manufactured in several steps. First the patients blood is run through a machine in a process known as leukapheresis. During the process, some of the patients immune cells are collected. These immune cells are then exposed to a protein intended to stimulate and direct them against prostate cancer. Following this exposure, the activated immune cells are then returned to the patient to treat the prostate cancer.
Provenge is administered intravenously in a three-dose schedule at approximately two week intervals. Each dose is preceded by the leukapheresis procedure approximately three days prior to the scheduled treatment, and is administered only to the patient from whom the cells were obtained.
The active components of Provenge are autologous antigen presenting cells ( APCs ) and the protein called PAP-GM-CSF. APCs are activated during a defined culture period with a recombinant human protein, PAP-GM-CSF, consisting of prostatic acid phosphatase ( PAP ), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor ( GM-CSF ), an immune cell activator.
The cellular composition of Provenge will vary, depending on the cells obtained from the individual patient during leukapheresis. In addition to the APCs, the product also contains T cells, B cells, natural killer ( NK ) cells, and other cells.
Each dose of Provenge is suspended in 250 mL of Lactated Ringers Injection, USP in a sealed, patient-specific infusion bag. Provenge contains no preservatives or adjuvants.
Provenge is specifically indicated for the treatment of asymptomatic or minimally symptomatic metastatic hormone refractory prostate cancer. The indication for use was approved based on the specific population studied in the clinical trials, which were patients with metastatic hormone refractory prostate cancer who had minimal or no symptoms such as pain caused by the prostrate cancer.
The use of either chemotherapy or immunosuppressive agents ( such as systemic corticosteroids ) given at the same time with the leukapheresis procedure for has not Provenge been studied.
Provenge is designed to stimulate the immune system, and using immunosuppressive agents at the same time may alter the effectiveness and/or safety of Provenge. Therefore, patients should be carefully evaluated to determine whether it is medically appropriate to reduce or discontinue immunosuppressive agents prior to treatment with Provenge.
Provenge is not limited to a specific age group. However, prostate cancer is more common in elderly men. In controlled clinical trials, the majority of the men were 65 years of age or older.
Common adverse reactions reported during a safety evaluation of 601 patients who received Provenge were chills, fatigue, fever, back pain, nausea, joint ache and headache. The majority of adverse reactions were mild or moderate in severity. Serious adverse reactions that were reported in patients receiving Provenge included some acute infusion reactions and stroke.
The effectiveness of Provenge was studied in 512 patients with metastatic hormone refractory prostate cancer in a randomized, double-blind, placebo-controlled, multicenter trial. The study showed an increase in overall survival of approximately 4 months for patients receiving Provenge treatments as compared to the control group.
Source: FDA, 2010