EU/3/21/2481: Orphan designation for the treatment of diffuse large B-cell lymphoma

Loncastuximab tesirine


This medicine was designated as an orphan medicine for the treatment of diffuse large B-cell lymphoma in the European Union on 20 August 2021.

This means that the developer will receive scientific and regulatory support from EMA to advance their medicine to the stage where they can apply for a marketing authorisation.

Orphan designation does not mean the medicine is available or authorised for use. All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.

During the medicine's development, doctors may be able to enrol patients in clinical trials investigating the medicine. For information on ongoing clinical trials in the EU, see:

Please note that this product (marketed as Zynlonta) was withdrawn from the Union Register of orphan medicinal products by the European Commission in November 2022 at the time of the granting of a marketing authorisation.

Key facts

Active substance
Loncastuximab tesirine
Intended use
Treatment of diffuse large B-cell lymphoma
Orphan designation status
EU designation number
Date of designation

ADC Therapeutics (NL) B.V
Laarderhoogtweg 25
1101 EB

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of loncastuximab tesirine (Zynlonta) at the time of marketing authorisation, and recommended that the orphan designation should not be maintained.

More information is available in the PDF icon orphan medicine assessment report .

Update history

November 2022Product withdrawn from the Union Register of orphan medicinal products by the European Commission
April 2022The sponsorship was transferred to ADC Therapeutics (NL) B.V., Netherlands. 

Documents related to this orphan designation evaluation

Patients' organisations

For contact details of patients’ organisations whose activities are targeted at rare diseases, see:

  • European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.

  • Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.

EU register of orphan medicines

The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:

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