Imfinzi

Imfinzi can only be obtained with a prescription and treatment should be started and supervised by a doctor experienced in treating cancer. It is given by infusion (drip) into a vein.

The dose of Imfinzi and how often it is given depends on the type of cancer being treated. Treatment can continue for as long as the patient benefits from it or for up to 1 year for NSCLC.

Treatment may be paused or stopped permanently if the patient gets severe side effects.

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 attach to a protein called 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 effective in two main studies.

In one main study of 713 patients with advanced NSCLC, patients given Imfinzi lived on average for around 17 months without their disease getting worse, compared with 6 months for those given placebo (a dummy treatment). Preliminary results also indicated that patients given Imfinzi lived longer overall compared with patients on placebo.

In another main study of 805 patients with extensive-stage SCLC, patients given Imfinzi together with chemotherapy lived on average for 13 months compared with 10 months for those given chemotherapy alone.

The most common side effects with Imfinzi given alone (which may affect more than 1 in 10 people) are cough, nose and throat infections, fever, diarrhoea, abdominal (belly) pain, rash, itching and hypothyroidism (an underactive thyroid gland).

The most common side effects with Imfinzi given together with chemotherapy (which may affect more than 1 in 5 people) are leucopenia (low levels of white blood cells, including neutrophils which fight infections), anaemia (low levels of red blood cells), thrombocytopenia (low blood platelet counts), nausea (feeling sick), tiredness and hair loss.

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

Imfinzi was shown to increase the time patients with advanced NSCLC lived without their disease getting worse and the time patients with extensive SCLC lived overall. This was considered important because these patients have few treatment options. The use of Imfinzi in patients with NSCLC is restricted to those whose cancer produces 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.