EU/3/08/595: Orphan designation for the treatment of peripheral T-cell lymphoma
monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E
Table of contents
Overview
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.
On 21 August 2019 orphan designation EU/3/08/595 was granted by the European Commission to Takeda Pharma A/S, Denmark, for the amended indication: treatment of peripheral T-cell lymphoma.
The sponsor’s address was updated in August 2020.
Key facts
Active substance |
monoclonal antibody against human CD30 covalently linked to the cytotoxin monomethylauristatin E
|
Medicine name |
Adcetris
|
Intended use |
Treatment of peripheral T-cell lymphoma
|
Orphan designation status |
Positive
|
EU designation number |
EU/3/08/595
|
Date of designation |
21/09/2019
|
Sponsor |
Takeda Pharma A/S |
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.
Recommendation for maintenance of orphan designation at the time of marketing authorisation: Adcetris (brentuximab vedotin) for the treatment of anaplastic large cell lymphoma (PDF/107.28 KB)
First published: 28/11/2012
Last updated: 28/11/2012
EMA/COMP/601842/2012
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: