Zynlonta
loncastuximab tesirine
Table of contents
Overview
Zynlonta is a medicine for treating two types of B-cell lymphoma (a type of blood cancer):
- diffuse large B-cell lymphoma (DLBCL);
- high-grade B-cell lymphoma (HGBL).
Zynlonta is used to treat adults with B-cell lymphoma that has come back (relapsed) after two or more treatments or that did not respond to previous treatment (refractory).
Diffuse large B-cell lymphoma is rare, and Zynlonta was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 20 August 2021. Further information on the orphan designation can be found here: https://www.ema.europa.eu/en/medicines/human/orphan-designations/eu-3-21-2481
Zynlonta contains the active substance loncastuximab tesirine.
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List item
Zynlonta : EPAR - Medicine Overview (PDF/160.19 KB)
First published: 26/01/2023
EMA/775362/2022 -
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List item
Zynlonta : EPAR - Risk Management Plan (PDF/936.19 KB)
First published: 26/01/2023
Authorisation details
Product details | |
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Name |
Zynlonta
|
Agency product number |
EMEA/H/C/005685
|
Active substance |
loncastuximab tesirine
|
International non-proprietary name (INN) or common name |
loncastuximab tesirine
|
Therapeutic area (MeSH) |
|
Anatomical therapeutic chemical (ATC) code |
L01FX22
|
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. |
Publication details | |
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Marketing-authorisation holder |
Swedish Orphan Biovitrum AB
|
Revision |
2
|
Date of issue of marketing authorisation valid throughout the European Union |
20/12/2022
|
Contact address |
SE-112 76 Stockholm |
Product information
28/04/2023 Zynlonta - EMEA/H/C/005685 - IB/0004
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
Antineoplastic agents
Therapeutic indication
Zynlonta as monotherapy is indicated for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) and high-grade B-cell lymphoma (HGBL), after two or more lines of systemic therapy.