EU/3/13/1119: Orphan designation for the treatment of follicular thyroid cancer



Please note that this product (marketed as Lenvima) was withdrawn from the Community Register of designated orphan medicinal products in August 2018 upon request of the marketing authorisation holder.

On 26 April 2013, orphan designation (EU/3/13/1119) was granted by the European Commission to Eisai Europe Limited, United Kingdom, for lenvatinib for the treatment of follicular thyroid cancer.

Lenvatinib (Lenvima) has been authorised in the EU since 28 May 2015 for the treatment of adult patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma (DTC), refractory to radioactive iodine (RAI).

The sponsorship was transferred to Eisai GmbH, Germany, in June 2018.

Key facts

Active substance
Medicine name
Intended use
Treatment of follicular thyroid cancer
Orphan designation status
EU designation number
Date of designation

Eisai GmbH
Lyoner Straße 36
60528 Frankfurt am Main
Tel. +49 (69) 66585-43

Review of designation

During its meeting of 14 to 16 April 2015, the Committee for Orphan Medicinal Products (COMP) reviewed the designations EU/3/13/1119 and EU/3/13/1121 for Lenvima (lenvatinib) as an orphan medicinal product for the treatment of follicular and papillary thyroid cancers. The COMP assessed whether, at the time of marketing authorisation, the medicinal product still met the criteria for orphan designation. The Committee looked at the seriousness and prevalence of the conditions, and the existence of other methods of treatment. As other methods of treatment are authorised in the European Union (EU), the COMP also considered whether the medicine is of significant benefit to patients with follicular and papillary thyroid cancer. The COMP recommended that the orphan designation of the medicine be maintained*.

*The maintenance of the orphan designation at time of marketing authorisation would, except in specific situations, give an orphan medicinal product 10 years of market exclusivity in the EU. This means that in the 10 years after its authorisation similar products with a comparable therapeutic indication cannot be placed on the market.

Documents related to this orphan designation evaluation

  • List item

    Recommendation for maintenance of orphan designation at the time of marketing authorisation: Lenvima (lenvatinib) for the treatment of follicular and papillary thyroid cancers (PDF/80.19 KB)

    First published: 29/06/2015
    Last updated: 29/06/2015

  • 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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