Lunsumio
mosunetuzumab
Table of contents
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 rare, and Lunsumio was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 16 November 2021. Further information on the orphan designation can be found here: https://www.ema.europa.eu/en/documents/orphan-maintenance-report/lunsumi...
Lunsumio contains the active substance mosunetuzumab.
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Lunsumio : EPAR - Medicine overview (PDF/110.04 KB)
First published: 23/06/2022
EMA/318043/2022 -
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Lunsumio : EPAR - Risk-management-plan summary (PDF/103.24 KB)
First published: 23/06/2022
Authorisation details
Product details | |
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Name |
Lunsumio
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Agency product number |
EMEA/H/C/005680
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Active substance |
mosunetuzumab
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International non-proprietary name (INN) or common name |
mosunetuzumab
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Therapeutic area (MeSH) |
Lymphoma, Follicular
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Anatomical therapeutic chemical (ATC) code |
L01FX25
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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. |
Publication details | |
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Marketing-authorisation holder |
Roche Registration GmbH
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Revision |
2
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Date of issue of marketing authorisation valid throughout the European Union |
03/06/2022
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Contact address |
Emil-Barell-Strasse 1 |
Product information
19/10/2023 Lunsumio - EMEA/H/C/005680 - IB/0007/G
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).
You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.
Pharmacotherapeutic group
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Antineoplastic agents
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Monoclonal antibodies
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.