On 11 January 2012, orphan designation (EU/3/11/939) was granted by the European Commission to Takeda Global Research and Development Centre (Europe) Ltd, United Kingdom, for brentuximab vedotin for the treatment of cutaneous T-cell lymphoma.

The sponsorship was transferred to Takeda Pharma A/S, Denmark, in October 2013.

Brentuximab vedotin in treatment of cutaneous T-cell lymphoma has been authorised in the EU as Adcetris since 15 December 2017.

For a list of the administrative updates to this public summary of opinion, please refer to the PDF document below.

Key facts

Active substance
Brentuximab vedotin
Medicine name
Disease / condition
Treatment of cutaneous 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 marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the .

Sponsor's contact details

Takeda Pharma A/S
Dybendal Alle 10
2630 Taastrup
Tel. +45 46 77 1036

Patients' organisations

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.

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