EU/3/11/939: Orphan designation for the treatment of cutaneous T-cell lymphoma

Brentuximab vedotin


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.

The sponsor’s address was updated in August 2020. 

Key facts

Active substance
Brentuximab vedotin
Medicine name
Intended use
Treatment of cutaneous T-cell lymphoma
Orphan designation status
EU designation number
Date of designation

Takeda Pharma A/S
Delta Park 45
2665 Vallensbaek Strand
Tel: +45 4677 1111

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 orphan maintenance assessment report.

Documents related to this orphan designation evaluation

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:

Related content

How useful was this page?

Add your rating