EU/3/11/933: Orphan designation for the treatment of pancreatic cancer

Nanoliposomal irinotecan


On 9 December 2011, orphan designation (EU/3/11/933) was granted by the European Commission to Merrimack Pharmaceuticals UK Limited, United Kingdom, for nanoliposomal irinotecan for the treatment of pancreatic cancer.

The sponsorship was transferred to Baxter Innovations GmbH, Austria, in December 2014.

The sponsorship was transferred to Les Laboratoires Servier, France, in December 2018.

Nanoliposomal irinotecan has been authorised in the EU as Onivyde since 14 October 2016.


Key facts

Active substance
Nanoliposomal irinotecan
Medicine name
Intended use
Treatment of pancreatic cancer
Orphan designation status
EU designation number
Date of designation

Les Laboratoires Servier
50 rue Carnot
92284 Suresnes Cedex
Tel. +33 1 55 72 60 00

Review of designation

During its meeting of 6-8 September 2016, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/11/933 for Onivyde (irinotecan1), as an orphan medicinal product for the treatment of pancreatic cancer. 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 condition, 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 pancreatic cancer. The COMP recommended that the orphan designation of the medicine be maintained2.

1Previously known as liposomal irinotecan.

2The 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 the same 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: Onivyde (irinotecan) for the treatment of pancreatic cancer (PDF/80.52 KB)


    First published: 11/11/2016
    Last updated: 11/11/2016

  • 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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