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.
Humanised Fc engineered monoclonal antibody against CD19 (tafasitamab)
Treatment of chronic lymphocytic leukaemia / small lymphocytic lymphoma
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Review of designation
Documents related to this orphan designation evaluation
EU/3/14/1286: Public summary of opinion on orphan designation: Humanised Fc engineered monoclonal antibody against CD19 for the treatment of chronic lymphocytic leukaemia/small lymphocytic lymphoma (PDF/123.51 KB)
First published: 16/07/2014
Last updated: 16/07/2014
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: