Breyanzi

Breyanzi is prepared using the patient’s own white blood cells. These are extracted from blood, genetically modified in the laboratory, and then administered back to the patient.

The medicine 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 treatment with Breyanzi, the patient should have a short course of chemotherapy to clear away their existing white blood cells, and just before the infusion they should be given paracetamol and an antihistamine medicine to reduce the risk of reactions to the infusion.

A medicine called tocilizumab (or a suitable alternative if this is unavailable due to a shortage) 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 one week after treatment and are advised to stay close to a specialist hospital for at least 4 weeks after treatment.

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

Breyanzi contains lisocabtagene maraleucel, which is a combination of two types of the patient’s white blood cells (CD4+ T cells and CD8+ T cells). These T cells have been genetically modified in the laboratory to make a protein called chimeric antigen receptor (CAR). CAR can attach to CD19, a protein that is found on the surface of cancer cells.

When Breyanzi is given to the patient, the modified T cells attach to CD19 proteins on the cancer cells and kill them, thereby helping to clear the cancer from the body.

Benefits of Breyanzi were shown in two main studies conducted in more than 300 adult patients with DLBCL that was not responding to previous treatment or had returned. These studies showed that 53% and 33% of patients treated with Breyanzi had a complete response (meaning that they had no signs of cancer after treatment) and 73% and 61% had at least a partial response. Comparable responses were seen in an analysis in a smaller number of patients with PMBCL and FL3B who participated in these studies.

These results were at least as good as the results seen in other studies of patients receiving standard cancer treatments.

The most common side effects with Breyanzi (which may affect more than 1 in 10 people) are decreases in neutrophils (a type of white blood cell that fights infections), in red blood cells or in blood platelets (components that help the blood to clot), as well as cytokine release syndrome (a potentially life-threatening condition that can cause fever, vomiting, shortness of breath, pain and low blood pressure) and tiredness. The most common serious side effects (which may affect more than 1 in 100 people) are cytokine release syndrome, encephalopathy (a brain disorder), very low levels of neutrophils or blood platelets, infections and fever, aphasia (speech problems), delirium (confusion), shaking or low blood pressure.

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

Breyanzi was shown to be at least as effective as existing treatment options for DLBCL, PMBCL and FL3B. Serious side effects, particularly cytokine release syndrome, can occur. However, these are manageable if appropriate measures are in place (see below). The European Medicines Agency therefore decided that the benefits of Breyanzi are greater than its risks and it can be authorised for use in the EU.

The company that markets Breyanzi must ensure that hospitals where Breyanzi is given have appropriate expertise, facilities and training. Tocilizumab, or suitable alternatives in case of its unavailability due to shortage, must be available for the management of cytokine release syndrome. The company must provide educational materials for healthcare professionals and patients about possible side effects, especially cytokine release syndrome.

The company must provide additional data from ongoing and future studies to further characterize the long-term safety and effectiveness of Breyanzi.

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

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

Breyanzi received a marketing authorisation valid throughout the EU on 4 April 2022.