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This is a summary of the European public assessment report (EPAR) for Zaltrap. It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. It is not intended to provide practical advice on how to use Zaltrap.
For practical information about using Zaltrap, patients should read the package leaflet or contact their doctor or pharmacist.
Zaltrap can only be obtained with a prescription and treatment should be supervised by a doctor who is experienced in using cancer medicines.
Zaltrap is given as an infusion (drip) into the vein over one hour, at a dose of 4 mg per kilogram body weight. This is then followed by the FOLFIRI treatment. This cycle of treatment is repeated every two weeks, until the disease gets worse or the patient cannot tolerate the treatment. Treatment should be discontinued, delayed, or the dose may have to be adjusted, in patients who develop certain side effects. For further details, see the package leaflet.
The active substance in Zaltrap, aflibercept, is a protein that attaches to vascular endothelial growth factor (VEGF) and placenta growth factor (PlGF), substances that circulate in the blood and make blood vessels grow. By binding to VEGF and PlGF, aflibercept stops them having an effect. As a result, the cancer cells cannot develop their own blood supply and are starved of oxygen and nutrients, so helping to slow down the growth of tumours.
Zaltrap was investigated in one main study involving 1,226 adults with metastatic colorectal cancer that had not responded to oxaliplatin-based treatment. Zaltrap was compared with placebo (a dummy treatment) when added to FOLFIRI. The main measure of effectiveness was the average length of time that patients survived after treatment.
In this study, Zaltrap was more effective than placebo at increasing survival of patients: patients treated with Zaltrap plus FOLFIRI lived an average of 13.5 months, whereas patients treated with placebo and FOLFIRI lived an average of 12.1 months.
Although Zaltrap is associated with significant side effects, which can be severe enough to force treatment to be stopped, the results of the large main study show that there is a small but clinically significant benefit in prolonging the life of treated patients in whom previous treatment failed. Overall, the European Medicines Agency decided that Zaltrap’s benefits are greater than its risks and recommended that it be approved for use in the EU.
The most common side effects with Zaltrap in combination with FOLFIRI (which may affect more than 20 patients in 100) are leucopenia and neutropenia (low levels of white cells in the blood, including the type that fight infections), diarrhoea, proteinuria (protein in the urine), increased blood levels of liver enzymes (aspartate and alanine transaminases), stomatitis (inflammation of the mouth), tiredness, thrombocytopenia (low blood platelet counts), hypertension (high blood pressure), weight loss, decreased appetite, epistaxis (nose bleeds), abdominal pain, dysphonia (speech disturbance), increases in creatinine in the blood (a marker of kidney problems), and headache. The most common effects that led to treatment being permanently stopped were problems with the circulation including hypertension, infections, tiredness, diarrhoea, dehydration, stomatitis, neutropenia, proteinuria, and pulmonary embolism (a clot in a blood vessel supplying the lungs).
Although medicines containing the same active substance are available for injection into the eye, Zaltrap must not be injected into the eye as it was not developed for such use and may cause local damage.
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