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

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

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 icon 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.

Documents related to this orphan designation evaluation

  • List item

    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)

    Adopted

    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:

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