EU/3/15/1494: Orphan designation for the treatment of diffuse large B-cell lymphoma

Humanised anti-CD37 monoclonal antibody conjugated to maytansinoid DM1 (naratuximab emtansine)

Overview

Please note that this product was withdrawn from the Union Register of orphan medicinal products in July 2022 on request of the Sponsor.

On 21 May 2015, orphan designation (EU/3/15/1494) was granted by the European Commission to ImmunoGen Europe Limited, United Kingdom, for humanised anti-CD37 monoclonal antibody conjugated to maytansinoid DM1 for the treatment of diffuse large B-cell lymphoma.

This medicine is now known as naratuximab emtansine.

Key facts

Active substance
Humanised anti-CD37 monoclonal antibody conjugated to maytansinoid DM1 (naratuximab emtansine)
Intended use
Treatment of diffuse large B-cell lymphoma
Orphan designation status
Withdrawn
EU designation number
EU/3/15/1494
Date of designation
18/07/2022
Sponsor

Voisin Consulting S.A.R.L.
64 Avenue Pierre Grenier
92100 Boulogne-Billancourt
France
Tel: +33 (0)1 41 31 83 00
E-mail : orphan@voisinconsulting.com

Review of designation

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

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:

How useful was this page?

Add your rating