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 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 and subsequently to Takeda Pharma A/S, Denmark, in October 2013.
Monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E has been authorised in the EU as Adcetris since 25 October 2012.
For a list of the administrative updates to this public summary of opinion please refer to the PDF document below.
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 for the treatment of anaplastic large cell lympho... (PDF/130.08 KB)
First published: 15/05/2009
Last updated: 13/05/2015
monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E (brentuximab vedotin)
|Disease / condition||
Treatment of anaplastic large cell lymphoma
|Date of first decision||
|EU designation number||
Review of designation
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 maintained.
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:
- Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe;
- European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.