PLEASE NOTE: MEDICINAL PRODUCT IS NO LONGER AUTHORIZED
What is Provenge and what is Cellular Immunotherapy used for?
Provenge is an anticancer medicine prepared specifically for each patient using its immune cells (cells that form the body's natural defense system). Provenge is indicated for the treatment of prostate cancer (a gland in the male reproductive system) in adult men who do not report symptoms or who report only a few symptoms. It is indicated when the carcinoma is metastatic (it has spread to other parts of the body) and when the medical or surgical castration (interruption of the production of male hormones) has not worked or has ceased to function but the treatment with chemotherapy (medicines that kill cells that reproduce rapidly, such as cancer cells) are still not considered appropriate. This type of prostate cancer is called "castration-resistant metastatic prostate cancer". Provenge is a type of advanced therapy medicine called a "somatic cell therapy product", which is a type of medicine containing cells or tissues that have been manipulated so that they can be used to treat, diagnose or prevent a disease.
How is Provenge used - Cellular Immunotherapy?
Provenge can only be obtained with a prescription. It must be administered under the supervision of a doctor experienced in the health treatment of prostate cancer, in an environment where resuscitation equipment is available.
Provenge is available as a liquid dispersion by infusion (drip) into a vein. Three days before the infusion, a procedure called leukapheresis should be conducted in order to collect immune cells from the patient's blood and transmit them to a facility where the medicine will be prepared. Once ready, the medicine is given by infusion over about 1 hour. Leukapheresis and infusion are repeated on two other occasions, each approximately 2 weeks apart. About half an hour before each infusion, the patient should take paracetamol and an antihistamine to reduce the reactions to infusion of Provenge. The patient should be monitored for at least half an hour after the infusion. For more information, see the package leaflet.
How does Provenge - cellular immunotherapy work?
Provenge is an immunotherapy, which is a medicine that stimulates the immune system to kill cancer cells. Contains immune cells extracted from the patient's blood. After collection these cells are mixed outside the patient's body with a "fusion protein" extracted from the cells themselves. The fusion protein consists of prostatic acid phosphatase (PAP), a molecule found in most prostate cancer cells, linked to the stimulating factor of the formation of colonies of granulocyte macrophages (GM-CSF), a molecule that activates immune cells . When the immune cells are re-administered to the patient by infusion, they stimulate against the PAP an immune response such that the immune system attacks and kills cancer cells because they contain this protein.
What benefit has Provenge shown: Cellular immunotherapy during the studies?
In comparison with placebo (a substance without effects on the body) Provenge has been shown to improve the overall survival (mean life expectancy) of patients with castration-resistant metastatic prostate cancer. In one main study involving 512 patients, the average overall survival of patients treated with Provenge was 25.8 months compared to 21.7 months for patients who received placebo.
What is the risk associated with Provenge - Cellular Immunotherapy?
The most common side effects with Provenge (which may affect more than 1 in 10 people) are chills, fatigue, pyrexia (fever), nausea, arthralgia (joint pain), headache and vomiting. Serious side effects of Provenge include acute infusion reactions, severe infection (catheter sepsis and staphylococcal bacteremia), heart attack and cerebrovascular events (related to blood supply to the brain). For the full list of all side effects reported with Provenge, see the package leaflet.
Why has Provenge - Cellular Immunotherapy been approved?
The Agency's Committee for Medicinal Products for Human Use (CHMP) decided that Provenge's benefits are greater than its risks and recommended that it be approved for use in the EU. The CHMP concluded that the improvement in overall survival observed with Provenge is important for patients. As for safety, the CHMP noted that it was generally well tolerated. The main risks included acute infusion reactions, toxicity associated with the leukapheresis procedure and infections, but the CHMP considered that these undesirable effects are manageable and adequately controlled with the risk reduction measures foreseen for this medicine.
What measures are being taken to ensure the safe and effective use of Provenge - Cellular Immunotherapy?
A risk management plan has been developed to ensure that Provenge is used as safely as possible. Based on this plan, safety information has been included in the summary of product characteristics and the information sheet for Provenge, including the appropriate precautions to be followed by healthcare professionals and patients. In addition, the company that markets Provenge will provide information material for doctors and patients containing instructions on how to use the medicine and how to perform the leukapheresis procedure. It will also provide tabs on which patients will be able to record scheduled dates for leukapheresis and infusion. The company will eventually establish a European register of patients treated with Provenge in order to monitor general survival and reported side effects (in particular stroke and heart attack), and will make data available from a US registry. Further studies will be conducted to collect additional data to support the effectiveness of Provenge.
Other information on Provenge - Cellular immunotherapy
On 6 September 2013, the European Commission issued a marketing authorization for Provenge, valid throughout the European Union. For more information about treatment with Provenge, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Last update of this summary: 09-2013
