EU/3/18/1994: Orphan designation for the treatment of biliary tract cancer
Table of contents
On 21 March 2018, orphan designation (EU/3/18/1994) was granted by the European Commission to QRC Consultants Ltd, United Kingdom, for ivosidenib for the treatment of biliary tract cancer.
Ivosidenib for treatment of biliary tract cancer has been authorised in the EU as Tibsovo since 4 May 2023.
Treatment of biliary tract cancer
|Orphan designation status||
|EU designation number||
|Date of designation||
Les Laboratoires Servier
Review of designation
The Committee for Orphan Medicinal Products reviewed the orphan designation of Tibsovo at the time of marketing authorisation, and confirmed that the orphan designation should be maintained.
More information is available in the orphan medicine assessment report .
|June 2021||The sponsorship was transferred to Les Laboratoires Servier, France.|
|December 2020||The sponsorship was transferred to Agios Netherlands B.V., Netherlands.|
|August 2018||The sponsorship was transferred to Quality Regulatory Clinical Ireland Limited, Ireland.|
Documents related to this orphan designation evaluation
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: