Please note that this product was withdrawn from the Community Register of designated orphan medicinal products by the European Commission in July 2019 at the time of withdrawal of the marketing authorisation.
On 12 February 2015, orphan designation (EU/3/15/1447) was granted by the European Commission to Elli Lilly Nederland B.V., the Netherlands, for olaratumab for the treatment of soft tissue sarcoma.
Olaratumab was authorised in the EU as Lartruvo since 9 November 2016.
The marketing authorisation was withdrawn on 23 July 2019.
Treatment of soft tissue sarcoma
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Review of designation
During its meeting of 4-6 October 2016, the Committee for Orphan Medicinal Products (COMP) reviewed the designation EU/3/15/1447 for Lartruvo (olaratumab) as an orphan medicinal product for the treatment of soft tissue sarcoma. 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 soft tissue sarcoma. The COMP recommended that the orphan designation of the medicine be maintained1.
1The 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
Recommendation for maintenance of orphan designation at the time of marketing authorisation: Lartruvo (olaratumab) for the treatment of soft tissue sarcoma (PDF/126.2 KB)
First published: 23/11/2016
Last updated: 15/01/2020
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: