Imjudo

Imjudo can only be obtained with a prescription and treatment must be started and supervised by a doctor with experience in treating cancer.

Imjudo is given once, as a single infusion (drip) into a vein which lasts about an hour. The first dose of durvalumab is given on the same day as Imjudo. After that, it is given every four weeks on its own. 

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

The active substance in Imjudo, tremelimumab, is a monoclonal antibody (a type of protein). It is designed to attach to and block CTLA-4, a protein that controls the activity of T cells, which are part of the immune system (the body’s natural defences). By blocking CTLA-4, the medicine increases the number and activity of T cells, which can then kill cancer cells. This is expected to slow down the spread of the cancer.

In a main study in patients with advanced hepatocellular carcinoma who had not been treated before and whose cancer cannot be removed by surgery, Imjudo in combination with durvalumab increased the time patients lived overall compared with standard treatment (sorafenib): patients who received Imjudo plus durvalumab (393 patients) lived on average 16.4 months compared with 13.8 months for those who received sorafenib (389 patients). In about 20% of patients who received Imjudo and durvalumab the tumour shrank or disappeared, and this response lasted about 22 months on average. About 5% of patients who received sorafenib had a response to treatment and their response lasted on average 18 months.

The most common side effects with Imjudo in combination with durvalumab (which may affect more than 1 in 10 people) are rash, pruritus (itching), diarrhoea, abdominal (belly) pain, increased levels of liver enzymes, fever, hypothyroidism (an underactive thyroid gland), cough, peripheral oedema (swelling especially of the ankles and feet) and increased level of lipase (an enzyme that helps digest fat, mainly made in the pancreas).

The most common serious side effects (which may affect up to 1 in 10 people) are colitis (inflammation in the large bowel), diarrhoea, pneumonia (infection of the lungs) and hepatitis (inflammation of the liver).

Imjudo is commonly associated with side effects related to the activity of the immune system on body organs, such as immune-mediated colitis, hepatitis and hypothyroidism.

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

Patients with advanced hepatocellular carcinoma whose cancer cannot be removed by surgery have a short life expectancy. Imjudo, given in combination with durvalumab, can increase the time people with hepatocellular carcinoma live compared to treatment with standard therapy. The side effects with Imjudo given in combination with durvalumab can be serious, but they are not more serious than those of the standard therapy. 

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

The company that markets Imjudo must provide healthcare professionals prescribing the medicine with educational materials on the side effects resulting from excessive activity of the immune system. Patients will also receive from their doctor an alert card summarising key safety information on the medicine.

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

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

Imjudo received a marketing authorisation valid throughout the EU on 20 February 2023.