Dispersion for infusion for the treatment of adults with relapsed or refractory (r/r) mantle cell lymphoma (MCL)

About the medicinal product

The medicinal product Breyanzi, containing the active substance lisocabtagene maraleucel, is an immunotherapy containing genetically modified autologous T cells. It is administered as an infusion into a vein.

Swissmedic first authorised Breyanzi on 28 February 2022 for the treatment of adults with specific types of blood cancer called "diffuse large B cell lymphoma” (DLBCL) and "primary mediastinal large B cell lymphoma" (PMBCL) after at least two prior therapies.

On 2 June 2025, an indication extension was authorised, permitting the use of Breyanzi for the treatment of adults with another specific type of blood cancer called “relapsed or refractory follicular lymphoma” (r/r FL).

Under this current indication extension, Breyanzi can now also be used to treat relapsed or refractory (r/r) mantle cell lymphoma (MCL) in adults who have had at least two lines of systemic therapy, including one Bruton’s tyrosine kinase (BTK) inhibitor.

Mantle cell lymphoma (MCL) is a rare but aggressive form of lymph node cancer. In MCL, certain white blood cells (B cells) undergo pathological change and grow uncontrolled.

Since these are rare and life-threatening diseases, Breyanzi has been authorised as an orphan drug. The term “orphan drug” refers to medicinal products used to treat patients with rare diseases.

Mode of action

The active substance lisocabtagene maraleucel is what is called a CD19-directed cellular immunotherapy (CAR-T cell therapy^[1]). This involves genetically modified immune cells from the patient’s own body (CAR-T cells) binding specifically to the CD19 antigen on the surface of B cells.

As they bind, they trigger downstream signals, activating the CAR-T cells and causing them to multiply.

^[1] _{CAR-T cell therapy: A specific cancer immunotherapy in which the patient’s own immune cells (T cells) are collected and genetically modified so they can recognise and specifically destroy cancer cells. The modified T cells (CAR-T) cells are administered to the patient by infusion.} 

Administration

Breyanzi is a prescription-only medicine.

The medicinal product Breyanzi is a dispersion for infusion containing CAR-positive viable T cells. Each vial contains 4.6 ml of cell suspension with an equal proportion of CD8+ and CD4+ cell components^[2] and is injected intravenously.

The recommended target dose of Breyanzi is 100 million CAR-T cells.

Treatment with Breyanzi is initiated and monitored by a healthcare professional with experience in the administration of cancer treatments.

Before receiving treatment with Breyanzi, patients are pretreated with chemotherapy.

Before using Breyanzi, the doctor will give the patient suitable medicines to minimise possible infusion reactions.

The therapy is administered in a treatment centre with direct access to appropriate intensive care units for the treatment of possible severe reactions.

^[2] _{CD4 and CD8 cells: CD4 (“helper”) and CD8 (“killer”) T cells are different immune cells in the immune system. The CD4 cells support and activate the CD8 cells, which specifically destroy the cancer cells. Both types of cell are required for effective, long-lasting treatment.}

Efficacy

The efficacy of Breyanzi was investigated in a study (TRANSCEND-MCL). The study included 88 adults with mantle cell lymphoma whose diseases had either returned after previous therapy or had not responded adequately to therapy.

The aim of the study was to assess whether the disease would respond to treatment with Breyanzi and, if so, how well. It was found that the majority of patients responded well to Breyanzi. As a result of treatment, the cancer could no longer be detected in a large proportion of patients (complete remission).

Precautions, undesirable effects, & risks

The medicinal product Breyanzi must not be used in those who are hypersensitive to the active substance or any of the excipients.

The most common undesirable effects (affecting more than one in ten users) are CRS^[3], reduced white blood cell count (neutropenia), reduced red blood cell count (anaemia), reduced blood platelet count (thrombocytopenia), fatigue and headache.

All precautions, risks, and other possible undesirable effects are listed in the Information for patients (package leaflet) and the Information for healthcare professionals.

^[3] _{CRS: Cytokine release syndrome is a systemic inflammatory response to the massive secretion of cytokines (proteins), which activate the white blood cells.}

Why the medicinal product has been authorised

The study demonstrated that the majority of patients responded to treatment with Breyanzi and a large proportion of them achieved remission.

Breyanzi offers patients with relapsed or refractory (r/r) mantle cell lymphoma (MCL) who have already undergone several treatments a treatment option for this serious and potentially life-threatening condition.

Taking all the risks and precautions into account, and based on the available data, the benefits of Breyanzi outweigh the risks.

Swissmedic has therefore authorised the indication extension for Breyanzi for the treatment of relapsed or refractory (r/r) mantle cell lymphoma (MCL) after at least two lines of systemic therapy, including one Bruton’s tyrosine kinase (BTK) inhibitor, in Switzerland.

Further information on the medicinal product

Information for healthcare professionals: 

Information for patients (package leaflet): 

Healthcare professionals can answer any further questions.

^{The date of revision of this text corresponds to that of the SwissPAR. New information concerning the authorised medicinal product in question will not be incorporated into the Summary report on authorisation.}

^{Swissmedic monitors medicinal products authorised in Switzerland. Swissmedic initiates the necessary action in the event of newly discovered adverse drug reactions or other safety-relevant signals. New findings that could impair the quality, efficacy, or safety of this medicinal product are recorded and published by Swissmedic. If necessary, the medicinal product information is adapted.}