Please note that this product (marketed as Vitrakvi) was withdrawn from the Community Register of designated orphan medicinal products in July 2019 upon request of the marketing authorisation holder at the time of the granting of a marketing authorisation.
On 11 January 2016, orphan designation (EU/3/15/1606) was granted by the European Commission to TMC Pharma Services Ltd, United Kingdom, for (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate (also known as LOXO-101) for the treatment of soft tissue sarcoma.
The sponsorship was transferred to Loxo Oncology Limited, United Kingdom in November 2017.
This medicine is now known as larotrectinib.
The sponsorship was transferred to Bayer AG - Germany, in June 2018.
(S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate (larotrectinib)
Treatment of soft tissue sarcoma
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Review of designation
Documents related to this orphan designation evaluation
EU/3/15/1606: Public summary of opinion on orphan designation: (S)-N-(5-((R)-2-(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin-3-yl)-3-hydroxypyrrolidine-1-carboxamide hydrogen sulfate for the treatment of s... (PDF/136.08 KB)
First published: 05/02/2016
Last updated: 24/10/2019
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: