EU/3/08/595

About

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
Disease / condition
Treatment of peripheral T-cell lymphoma
Date of first decision
21/09/2019
Outcome
Positive
EU designation number
EU/3/08/595

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 PDF iconorphan 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

Takeda Pharma A/S
Delta Park 45
2665 Vallensbaek Strand
Hovedstaden
Danmark
Tel: +45 4677 1111
E-mail: kristina.stovring@takeda.com

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.

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