EPAR summary for the public Oncept ILFeline interleukin2 recombinant canary pox virusThis document is a summary of the European Public Assessment Report Its purpose is to explain how 7 Westferry Cir ID: 961195
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EMA/151380/2013EMEA/V/C/002562 EPAR summary for the public Oncept ILFeline interleukin2 recombinant canary pox virusThis document is a summary of the European Public Assessment Report. Its purpose is to explain how 7 Westferry Circus Canary Wharf London E14 4HB United KingdomAn agency of the European Union Telephone+44 (0)20 7418 8400 How does Oncept ILwork?OnceptIL2 is an immunomodulating agent, whichmeans that it affects the activity of the immune system (the body’s natural defences). The active substance in Oncept IL‘carrier’ canarypox virus that containsthegene toproducethe protein feline interleukin2 works by stimulatingsome of the specialised cells of the immune system to attack the cancer cells. This is expected to kill the cancer cellsThe virus allows the production of IL2 in small amounts and for a prolonged time at the injection site. anarypox viruses do not spread or multiply in cats or in mammalOnceptIL2is produced by a method known as ‘recombinant DNA technology’: it contains virusesthat havereceived a gene (DN
A), which makes themable to produce ILHow has Oncept ILbeen studied?Oncept ILwas studied in two field studiesinvolving cats which had spontaneously developed fibrosarcomathat had not spreadto other parts of thebody. The two studies compared a total of cats treated with Oncept IL2 with control cats that just received surgery and radiotherapy.The main measure of effectiveness was the time until the tumors came back or spread(relapse)What benefit has Oncept ILshown during the studies?The studies showed thatin cats treated withOncept ILthe tumors took longer to come back over 730 daysbased on the mid value of the range) compared withcontrol cats(287 days). Oncept ILreduced the risk of relapse in the period from six months after the start of treatment by approximately 56% after one year and 65% after two years.What is the risk associated withOncept ILide effects that may be seen with Oncept ILtreatment are short lived apathy (lackof responsiveness) and hyperthermia (increasedbody temperature above 39.5from the normal value of 38 A moderate reactionthe
injection sitemay occur that involves signs of pain when the area is touched, swelling and scratching. It usually disappears spontaneously within one week.What are the precautions for the person who gives the medicine or comes into contact with the animal?If theproduct is accidentally selfinjectedmedical advice should be sought immediately and the package leaflet or label shown to the doctor.Why has Oncept ILbeen approved? The Committee for Medicinal Products for Veterinary Use (CVMP) concluded that the benefits of Oncept exced the risks for the approved indication and recommended that Oncept ILbe given a marketing authorisation.The benefitrisk balance may be found in the scientific discussion module of this EPAR. Oncept ILEMA/151380/2013Page Other information aboutOncept ILThe European Commission granted a marketing authorisation valid throughout the European Union,for Onept ILon 3/05/2013. Information on the prescription status of this product may be found on the label/outer package.This summary was last updated iMarch Oncept ILEMA/151380/2013Pag