EU/3/19/2220

About

On 13 November 2019, orphan designation EU/3/19/2220 was granted by the European Commission to Kite Pharma EU B.V., Netherlands, for autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (also known as KTE-X19 CAR) for the treatment of mantle cell lymphoma.

Key facts

Active substance
Autologous peripheral blood T cells CD4 and CD8 selected and CD3 and CD28 activated transduced with retroviral vector expressing anti CD19 CD28/CD3-zeta chimeric antigen receptor and cultured (KTE-X19)
Disease / condition
Treatment of mantle cell lymphoma
Date of first decision
13/11/2019
Outcome
Positive
EU designation number
EU/3/19/2220

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product it 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:

  • 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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