On 15 January 2009, orphan designation (EU/3/08/595) was granted by the European Commission to Seattle Genetics UK Limited, United Kingdom, for monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E (brentuximab vedotin) for the treatment of anaplastic large cell lymphoma.
The sponsorship was transferred to Takeda Global Research and Development Centre (Europe) Ltd, United Kingdom, in September 2010.
Brentuximab vedotin for treatment of peripheral T-cell lymphoma has been authorised in the EU as Adcetris since 30 October 2012.
The sponsorship was transferred to Takeda Pharma A/S, Denmark, in October 2013.
EU/3/08/595: Public summary of positive opinion for orphan designation of monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E (brentuximab vedotin) for the treatment of peripheral T-cell lymphoma (PDF/217.32 KB)
First published: 16/01/2020
monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E
|Disease / condition||
Treatment of peripheral T-cell lymphoma
|Date of first decision||
|EU designation number||
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Adcetris 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 orphan medicine assessment report.
During its meeting of 4-5 September 2012, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/08/595 for Adcetris (brentuximab vedotin1) as an orphan medicinal product for the treatment of anaplastic large cell lymphoma (ALCL). The COMP assessed whether, at the time of 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 satisfactory methods of treatment. As other satisfactory methods of treatment for patients with this condition are authorised in the European Union (EU), the COMP also looked at the significant benefit of the product over existing treatments. The COMP recommended that the orphan designation of the medicine be maintained2.
1Previously known as monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E.
2The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.
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.