EU/3/22/2732: Orphan designation for the treatment of acute lymphoblastic leukaemia

Autologous T-cells transduced with a lentiviral vector encoding a chimeric antigen receptor against CD7

Table of contents

Overview

This medicine was designated as an orphan medicine for the treatment of acute lymphoblastic leukaemia in the European Union on 9 December 2022.

This means that the developer will receive scientific and regulatory support from EMA to advance their medicine to the stage where they can apply for a marketing authorisation.

Orphan designation does not mean the medicine is available or authorised for use. All medicines, including designated orphan medicines, must be authorised before they can be marketed and made available to patients in the EU.

During the medicine's development, doctors may be able to enrol patients in clinical trials investigating the medicine. For information on ongoing clinical trials in the EU, see:

Key facts

Active substance
Autologous T-cells transduced with a lentiviral vector encoding a chimeric antigen receptor against CD7
Intended use
Treatment of acute lymphoblastic leukaemia
Orphan designation status
Positive
EU designation number
EU/3/22/2732
Date of designation
09/12/2022
Sponsor

FGK Representative Service GmbH
Heimeranstrasse 35
Schwanthalerhoehe-Laim
80339 Munich
Bavaria
Germany
E-mail: min.wang@persongen.com

Update history

DateUpdate
March 2023The sponsorship was transferred from Granzer Regulatory Consulting & Services GmbH, Germany to FGK Representative Service GmbH, Germany.

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:

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