loncastuximab tesirine

This medicine is authorised for use in the European Union.


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.

This EPAR was last updated on 02/05/2023

Authorisation details

Product details
Agency product number
Active substance
loncastuximab tesirine
International non-proprietary name (INN) or common name
loncastuximab tesirine
Therapeutic area (MeSH)
  • Lymphoma, Large B-Cell, Diffuse
  • Lymphoma, B-Cell
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional 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 approvalConditional 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
Marketing-authorisation holder
Swedish Orphan Biovitrum AB
Date of issue of marketing authorisation valid throughout the European Union
Contact address

SE-112 76 Stockholm

Product information

28/04/2023 Zynlonta - EMEA/H/C/005685 - IB/0004

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Product information documents contain:

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.

Assessment history

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