Refusal of orphan designation for the treatment of B-cell non-Hodgkin's lymphoma

ibritumomab tiuxetan

Table of contents


On 20 March 2001 the Committee for Orphan Medicinal Products (COMP) adopted a negative opinion on orphan designation of ibritumomab tiuxetan for use with 90Yttrium in the treatment of B-cell non-Hodgkin's lymphoma. A negative decision was adopted by the European Commission on 1 February 2002.

The sponsor, Schering AG, Germany, applied for orphan designation of ibritumomab tiuxetan for use with 90Yttrium for treatment of patients with CD20+ indolent B-cell non-Hodgkin`s lymphoma. This application was based on the severity and rarity of the condition, as well as on assumption of potential significant benefit despite currently available methods of treatment.

The negative opinion was based on the following grounds:

- For the purpose of designation as orphan medicinal product, limiting the indication to the subset proposed was not acceptable as an effect in a broader population (including aggressive B-cell non-Hodgkin`s lymphoma) had not been excluded.
- It had not been established that B-cell non-Hodgkin´s lymphoma (including both indolent and aggressive forms) affect not more than 5 in 10,000 persons in the Community.

Requests for designation as orphan medicinal products are made for investigational products. Absence of orphan designation does not preclude the development of this product, in particular through clinical trials, and subsequently the possibility of obtaining a marketing authorisation if quality, safety and efficacy are demonstrated.

Key facts

Active substance
ibritumomab tiuxetan
Intended use
Treatment of B-cell non-Hodgkin`s lymphoma
Orphan designation status
EU designation number
Date of refusal of designation
Schering AG
D-13342 Berlin
Tel. +49 3046 817953
Fax +49 3046 818007

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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