Imfinzi

Imfinzi is given as an infusion (drip) into a vein every 2 weeks. The dose is calculated based on the patient’s body weight. Treatment should continue for as long as the patient benefits from it or for up to 1 year. Treatment may be paused or stopped permanently if the patient experiences severe side effects.

Imfinzi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer.

For more information about using Imfinzi, see the package leaflet or contact your doctor or pharmacist.

The active substance in Imfinzi, durvalumab, is a monoclonal antibody, a type of protein designed to recognise and attach to a protein called ‘programmed death-ligand 1’ (PD-L1), which is present on the surface of many cancer cells.

PD-L1 acts to switch off immune cells that would otherwise attack the cancer cells. By attaching to PD- L1 and blocking its effects, Imfinzi increases the ability of the immune system to attack the cancer cells and thereby slow down the progression of the disease.

Imfinzi has been shown to be more effective than placebo (a dummy treatment) at prolonging the time patients with advanced non-small cell lung cancer lived without their disease getting worse. In one main study of 713 patients, patients given Imfinzi lived on average for around 17 months without their disease getting worse, compared with 6 months for those given placebo.

Preliminary results also indicated that patients given Imfinzi lived longer overall, compared with patients on placebo, though longer monitoring would be needed to confirm the extent of the benefit.

The most common side effects with Imfinzi (which may affect more than 1 in 5 people) are cough, nose and throat infections, and rash. The most common serious side effect (which may affect up to 1 in 10 people) is pneumonia (infection of the lungs).

For the full list of side effects and restrictions of Imfinzi, see the package leaflet.

Imfinzi was shown to improve the length of time patients with advanced NSCLC lived without their disease getting worse, and this was considered important for these patients, who have few treatment options. The use of Imfinzi is restricted to patients whose tumours produce PD-L1, since a clear benefit was only shown in this group of patients. Side effects with Imfinzi were considered manageable, and its safety profile acceptable and in line with that of similar medicines.

The European Medicines Agency therefore decided that Imfinzi’s benefits are greater than its risks and it can be authorised for use in the EU.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Imfinzi have been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Imfinzi are continuously monitored. Side effects reported with Imfinzi are carefully evaluated and any necessary action taken to protect patients.

Imfinzi received a marketing authorisation valid throughout the EU on 21 September 2018.