EU/3/16/1745

About

On 14 October 2016, orphan designation (EU/3/16/1745) was granted by the European Commission to Novartis Europharm Limited, United Kingdom, for autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 (also known as CTL019) for the treatment of diffuse large B-cell lymphoma.

This medicine is now known as tisagenlecleucel.

The sponsorship was transferred to Novartis Europharm Limited, Ireland, in May 2018.

Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 for treatment of diffuse large B-cell lymphoma has been authorised in the EU as Kymriah since 23 August 2018.

Key facts

Active substance
Autologous T cells transduced with lentiviral vector containing a chimeric antigen receptor directed against CD19 (tisagenlecleucel)
Disease / condition
Treatment of diffuse large B-cell lymphoma
Date of first decision
14/10/2016
Outcome
Positive
EU designation number
EU/3/16/1745

Review of designation

The Committee for Orphan Medicinal Products reviewed the orphan designation of Kymriah at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.

More information is available in the PDF iconorphan medicine assessment report .

Sponsor's contact details

Novartis Europharm Limited
Vista Building
Elm Park       
Merrion Road
Dublin 4
Ireland
Telephone: +41 613 241 111
E-mail: orphan.enquiries@novartis.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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