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

Loncastuximab tesirine

Table of contents


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:

The sponsorship was transferred to ADC Therapeutics (NL) B.V., Netherlands, in April 2022.

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

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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