On 27 October 2011, orphan designation (EU/3/11/924) was granted by the European Commission to Celgene Europe Limited, United Kingdom, for lenalidomide for the treatment of mantle cell lymphoma.
Update: lenalidomide for treatment of mantle cell lymphoma has been authorised in the EU as Revlimid since 8 July 2016.
The sponsorship was transferred to Celgene Europe B.V., The Netherlands, in July 2018.
|Disease / condition||
Treatment of mantle cell lymphoma
|Date of first decision||
|EU designation number||
Review of designation
During its meeting of 14-16 June 2016, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/11/924 for Revlimid (lenalidomide) as an orphan medicinal product for the treatment of mantle cell lymphoma. The COMP assessed whether, at the time of addition of a new indication to the marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the condition, and the existence of other methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with mantle cell lymphoma. The COMP recommended that the orphan designation of the medicine be maintained.
Recommendation for maintenance of orphan designation at the time of addition of a new indication to the marketing authorisation: Revlimid (lenalidomide) for the treatment of mantle cell lymphoma (PDF/131.08 KB)
First published: 20/07/2016
Last updated: 20/07/2016
Sponsor's contact details
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.