Human medicines European public assessment report (EPAR): Lunsumio, mosunetuzumab, Date of authorisation: 03/06/2022, Revision: 8, Status: Authorised

• Application under evaluation
• CHMP opinion
• European Commission decision

Overview

Lunsumio is a cancer medicine used to treat adults with follicular lymphoma that does not respond to (refractory), or has come back (relapsed) after, at least two previous treatments.

Follicular lymphoma is a cancer that affects a type of white blood cell called B lymphocytes.

Follicular lymphoma is rare, and Lunsumio was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 16 November 2021.

Lunsumio contains the active substance mosunetuzumab.

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How is Lunsumio used?

Lunsumio can only be obtained with a prescription and must be given under the supervision of a doctor who is qualified in the use of cancer medicines.

Lunsumio should be given in a facility with appropriate medical support to manage severe side effects such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). For more information about these possible side effects, see the section on risks below.

Lunsumio is given as an infusion (drip) into a vein or as an injection under the skin of the thigh or abdomen, in treatment cycles of 3 weeks. During the first cycle, the patient receives one infusion or injection a week, and each infusion lasts a few hours. In later cycles, one infusion or injection is given every 3 weeks, and the infusion may be given quicker if previous infusions were well tolerated.

Treatment with Lunsumio usually lasts 8 cycles, but up to 17 cycles may be given depending on how well the disease responds to treatment. However, the doctor may interrupt or stop treatment if the patient develops severe side effects.

To reduce the risk of CRS and infusion-related reactions, patients are given medicines before their first two doses of Lunsumio. If these reactions occur, patients will continue to receive these medicines before later doses.

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

How does Lunsumio work?

The active substance in Lunsumio, mosunetuzumab, is a monoclonal antibody (a type of protein) designed to attach to CD20, found on B lymphocytes, including the follicular lymphoma cells.

It also attaches to CD3, a protein found on T cells, another type of white blood cell. T cells are part of the immune system (the body’s natural defences). They help protect the body from infection and can also destroy cancer cells.

By attaching to both CD20 and CD3, Lunsumio brings the cancer cells and T cells together. This encourages T cells to destroy the follicular lymphoma cells.

What benefits of Lunsumio have been shown in studies?

The benefits of Lunsumio were evaluated in a study in adults with relapsed or refractory follicular lymphoma who had received at least two previous treatments. In this study, Lunsumio was not compared with any other medicines. In response to treatment, 80% (72 out of 90) of participants had their cancer shrink or disappear, with 54 out of 90 patients (60%) achieving a complete response (no detectable signs of cancer). On average, responses lasted for at least 12 months in 62% of patients.

What are the risks associated with Lunsumio?

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

The most common side effects with Lunsumio (which may affect more than 2 in 10 people) include cytokine release syndrome (a potentially life-threatening condition causing fever, vomiting, shortness of breath, headache and low blood pressure), neutropenia (low levels of neutrophils, a type of white blood cell), rash and upper respiratory tract infection (nose and throat infection).

Some side effects can be serious. The most frequent (which may affect more than 2 in 100 people) include cytokine release syndrome, fever, sepsis (when bacteria and their toxins circulate in the blood, leading to organ damage), upper respiratory tract infection and pneumonia (infection of the lungs).

Why is Lunsumio authorised in the EU?

Patients with relapsed or refractory follicular lymphoma have limited treatment options. Treatment with Lunsumio resulted in a complete response (no detectable signs of cancer) in more than half of the patients. Regarding safety, side effects were considered generally manageable and acceptable for the disease it is used for.

Lunsumio has been given ‘conditional authorisation’. This means that is has been authorised on the basis of less comprehensive data than are normally required because it fulfils an unmet medical need. The Agency considers that the benefits of having the medicine available earlier outweigh any risks associated with using it while waiting for further evidence.

The company must provide further data on Lunsumio. It must submit results from an ongoing study comparing Lunsumio with rituximab, both given with lenalidomide, in patients with follicular lymphoma who had received at least one previous treatment. Every year, the Agency will review any new information that becomes available.

What measures are being taken to ensure the safe and effective use of Lunsumio?

The company that markets Lunsumio must provide a patient card to all patients receiving the medicine. The card explains key signs and symptoms of CRS and ICANS, and advises on when to seek urgent medical help.

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

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

Other information about Lunsumio

Lunsumio received a conditional marketing authorisation valid throughout the EU on 3 June 2022.

Lunsumio : EPAR - Medicine overview

Reference Number:

EMA/236687/2022

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Lunsumio : EPAR - Risk management plan

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Product information

Lunsumio : EPAR - Product Information

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Latest procedure affecting product information:

VR/0000350590

30/06/2026

This medicine’s product information is available in all official EU languages. Select 'available languages' to access the language you need.

Product information documents contain:

• summary of product characteristics (annex I);
• manufacturing authorisation holder responsible for batch release (annex IIA);
• conditions of the marketing authorisation (annex IIB);
• labelling (annex IIIA);
• package leaflet (annex IIIB).

Lunsumio : EPAR - All authorised presentations

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Product details

Name of medicine

Lunsumio

Active substance

mosunetuzumab

International non-proprietary name (INN) or common name

mosunetuzumab

Therapeutic area (MeSH)

Lymphoma, Follicular

Anatomical therapeutic chemical (ATC) code

L01FX25

Pharmacotherapeutic group

• Antineoplastic agents
• monoclonal antibodies and antibody drug conjugates

Therapeutic indication

Lunsumio as monotherapy is indicated for the treatment of adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least two prior systemic therapies.

Authorisation details

EMA product number

EMEA/H/C/005680

Additional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.

Conditional approval

This medicine received a conditional marketing authorisation. This was granted in the interest of public health because the medicine addresses an unmet medical need and the benefit of immediate availability outweighs the risk from less comprehensive data than normally required. For more information, see Conditional marketing authorisation.

Orphan

This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Marketing authorisation holder

Roche Registration GmbH

Emil-Barell-Strasse 1 79639 Grenzach-Wyhlen Germany

Opinion adopted

22/04/2022

Marketing authorisation issued

03/06/2022

Revision

8

Assessment history

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Changes since initial authorisation of medicine

Lunsumio : EPAR - Procedural steps taken and scientific information after authorisation

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02/07/2026

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Lunsumio : EPAR - Procedural steps taken and scientific information after authorisation (archive)

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First published:

20/04/2023

Last updated:

02/07/2026

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Lunsumio-H-C-005680-X-0015 : EPAR - Assessment report - Variation

Adopted

Reference Number:

EMA/CHMP/289782/2025

English (EN) (8.49 MB - PDF)

First published:

16/02/2026

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CHMP post-authorisation summary of positive opinion for Lunsumio (X-15)

Adopted

Reference Number:

EMA/CHMP/289787/2025

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First published:

19/09/2025

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Lunsumio-H-C-PSUSA-00010999-202312 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMA/493647/2024

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First published:

22/10/2024

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Lunsumio-H-C-PSUSA-00010999-202306 : EPAR - Scientific conclusions and grounds for the variation to the terms of the marketing authorisation

Reference Number:

EMA/150756/2024

English (EN) (158.69 KB - PDF)

First published:

09/04/2024

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Initial marketing authorisation documents

Lunsumio : EPAR - Orphan maintenance assessment report (initial authorisation)

Adopted

Reference Number:

EMA/OD/0000082933

English (EN) (536.06 KB - PDF)

First published:

23/06/2022

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Lunsumio : EPAR - Public Assessment Report

Reference Number:

EMA/CHMP/63179/2022

English (EN) (10.43 MB - PDF)

First published:

23/06/2022

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CHMP summary of positive opinion for Lunsumio

Adopted

Reference Number:

EMA/CHMP/158054/2022

English (EN) (125.71 KB - PDF)

First published:

22/04/2022

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News on Lunsumio

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 15-18 September 2025

19/09/2025

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 April 2022

22/04/2022

More information on Lunsumio

• EMA/PE/0000181993 - paediatric investigation plan
• EU/3/21/2517 - orphan designation for treatment of follicular lymphoma

This page was last updated on

02/07/2026