EU/3/16/1694

About

On 14 July 2016, orphan designation (EU/3/16/1694) was granted by the European Commission to Adaptimmune Limited, United Kingdom, for autologous CD4+ and CD8+ T cells transduced with lentiviral vector containing an affinity-enhanced T-cell receptor targeting the New York esophageal antigen-1 for the treatment of soft tissue sarcoma.

The sponsorship was transferred to GlaxoSmithKline Trading Services Limited, Ireland, in August 2018.

The sponsor’s address was updated in April 2020. In April 2020, GlaxoSmithKline Trading Services Limited changed name to GlaxoSmithKline (Ireland) Limited.

Key facts

Active substance
autologous CD4+ and CD8+ T cells transduced with lentiviral vector containing an affinity-enhanced T-cell receptor targeting the New York esophageal antigen-1
Disease / condition
Treatment of soft tissue sarcoma
Date of first decision
14/07/2016
Outcome
Positive
EU designation number
EU/3/16/1694

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Sponsor's contact details

GlaxoSmithKline (Ireland) Limited
12 Riverwalk
Citywest Business Campus
Dublin 24
D24 YK11
Ireland
E-mail: customercontactuk@gsk.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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