EU/3/15/1579

About

On 11 November 2015, orphan designation (EU/3/15/1579) was granted by the European Commission to Kite Pharma UK, Ltd, United Kingdom, for autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor for the treatment of follicular lymphoma.

The sponsorship was transferred to Kite Pharma EU B.V., Netherlands, in April 2017.

Key facts

Active substance
Autologous T cells transduced with retroviral vector encoding an anti-CD19 CD28/CD3-zeta chimeric antigen receptor
Disease / condition
Treatment of follicular lymphoma
Date of first decision
11/11/2015
Outcome
Positive
EU designation number
EU/3/15/1579

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

Kite Pharma EU B.V.
Science Park 408
1098 XH Amsterdam
The Netherlands
Tel. +31 20 235 2630
E-mail: regulatory@kitepharma.com

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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