Tecartus

Tecartus is prepared using the patient’s own white blood cells which are extracted from the blood and genetically modified in the laboratory.

It must be given in a qualified treatment centre by a doctor with experience in the treatment of blood cancers and trained to give Tecartus. The medicine can only be obtained with a prescription.

It is given as a single infusion (drip) into a vein and must only be given to the patient whose cells were used to make it. Before receiving Tecartus, the patient should have a short course of chemotherapy to clear away their white blood cells, and just before the infusion the patient is given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion.

A medicine called tocilizumab and emergency equipment must be available in case the patient has a potentially serious side effect called cytokine release syndrome (see risks section below).

Patients should be closely monitored for side effects for 10 days after treatment and are advised to stay close to a specialist hospital for at least 4 weeks after treatment.

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

Tecartus contains the patient’s own T cells (a type of white blood cell) that have had the gene for a protein called chimeric antigen receptor (CAR) inserted in the laboratory, which helps the T cell recognise and kill cancer cells. The gene is inserted using a type of virus called a retrovirus that has been modified to carry the gene into the cells and does not cause disease. The modified T cells then make the CAR protein and present it on their surface. CAR can attach to another protein on the surface of cancer cells called CD19.

When Tecartus is infused to the patient, the modified T cells attach to and kill the cancer cells, thereby helping to clear the cancer from the body.

The main study, which is currently ongoing, involved 74 adults whose cancer had come back after at least two previous treatments including a BTK inhibitor. Around 59% of patients (44 out of 74) had a complete response (which means they had no signs of the cancer left). This was better than results previously seen in similar patients given other treatments.

In the clinical study, serious side effects occur in more than half of all patients. The most common serious side effects are cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure), encephalopathy (a brain disorder with headache, somnolence and mental confusion) and infections.

Patients with mantle cell lymphoma have poor outcomes, particularly if the cancer is not responding to a BTK inhibitor or comes back after therapy with a BTK inhibitor. Tecartus provides a treatment option for these patients. Although serious side effects occur in most patients and can include cytokine release syndrome, these are manageable if the appropriate measures are in place (see below). The European Medicines Agency therefore decided that Tecartus’ benefits are greater than its risks and it can be authorised for use in the EU.

Tecartus has been given ‘conditional authorisation’. This means that there is more evidence to come about the medicine, which the company is required to provide. Every year, the Agency will review any new information that becomes available and this overview will be updated as necessary.

Since Tecartus has been a given conditional authorisation, the company that markets the medicine will provide to the Agency the final reports of the currently ongoing study by 2022. The company should also carry out a study on the long-term effects and safety in women, the elderly and patients who are very ill with the disease.

The company that markets Tecartus must ensure that hospitals where Tecartus is given have appropriate expertise, facilities and training. Tocilizumab must be available in case of cytokine release syndrome. The company must provide educational materials for healthcare professionals and patients about possible side effects of Tecartus, especially cytokine release syndrome.

The company must carry out several studies to obtain more information on Tecartus including its safety and effectiveness in the long term.

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

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

Tecartus received a conditional marketing authorisation valid throughout the EU on 14 December 2020.