EU/3/14/1286: Orphan designation for the treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma

Humanised Fc engineered monoclonal antibody against CD19 (tafasitamab)

Overview

On 4 July 2014, orphan designation (EU/3/14/1286) was granted by the European Commission to MorphoSys AG, Germany, for humanised Fc engineered monoclonal antibody against CD19 for the treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma.

The sponsorship was transferred to Incyte Biosciences Distribution B.V., Netherlands, in November 2021.

Key facts

Active substance
Humanised Fc engineered monoclonal antibody against CD19 (tafasitamab)
Intended use
Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
Orphan designation status
Positive
EU designation number
EU/3/14/1286
Date of designation
04/07/2014
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 reviews the orphan designation of a product if it is approved for marketing authorisation.

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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