EU/3/09/650: Orphan designation for the treatment of acute lymphoblastic leukaemia



On 24 July 2009, orphan designation (EU/3/09/650) was granted by the European Commission to Micromet AG, Germany, for blinatumomab for the treatment of acute lymphoblastic leukaemia.

In January 2012, Micromet AG changed name to Micromet GmbH. In May 2012, Micromet GmbH changed name to Amgen Research (Munich) Gmbh.

The sponsorship was transferred to Amgen Europe BV, The Netherlands, in February 2014.

Update: Blinatumomab (Blincyto) has been authorised in the EU since 23 November 2015 for treatment of adults with Philadelphia chromosome negative relapsed or refractory B-precursor acute lymphoblastic leukaemia.

Key facts

Active substance
Intended use
Treatment of acute lymphoblastic leukaemia
Orphan designation status
EU designation number
Date of designation

Amgen Europe BV
Minervum 7061
4817 ZK Breda
The Netherlands
Tel. +31 765732000

Review of designation

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

More information is available in the below reports:

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Blincyto (blinatumomab) for the treatment of acute lymphoblastic leukaemia (PDF/79.7 KB)


    First published: 08/12/2015
    Last updated: 08/12/2015

  • 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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