EU/3/14/1424: Orphan designation for the treatment of diffuse large B-cell lymphoma

Humanised Fc engineered monoclonal antibody against CD19 (tafasitamab)

Overview

This medicine is now known as tafasitamab.

The medicinal product has been authorised in the EU as Minjuvi since 26 August 2021.

On 15 January 2015, orphan designation (EU/3/14/1424) was granted by the European Commission to MorphoSys AG, Germany, for humanised Fc engineered monoclonal antibody against CD19 for the treatment of diffuse large B-cell lymphoma.

The sponsorship was transferred to Incyte Biosciences Distribution B.V., Netherlands, in July 2020.

Key facts

Active substance
Humanised Fc engineered monoclonal antibody against CD19 (tafasitamab)
Intented use
Treatment of diffuse large B-cell lymphoma
Orphan designation status
Positive
EU designation number
EU/3/14/1424
Date of designation
15/01/2015
Sponsor

Incyte Biosciences Distribution B.V.
Paasheuvelweg 25
1105 BP Amsterdam 
Noord-Holland
Netherlands
E-mail: RA@incyte.com

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Minjuvi at the time of marketing authorisation, and confirmed that the orphan designation should be maintained. 

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

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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