On 12 October 2017, orphan designation (EU/3/17/1936) was granted by the European Commission to Worldwide Clinical Trials Limited, United Kingdom, for 1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea (also known as DCC-2618) for the treatment of gastrointestinal stromal tumours.
The sponsorship was transferred to Pharma Gateway AB, Sweden, in May 2018.
The sponsorship was transferred to Deciphera Pharmaceuticals (Netherlands) B.V., Netherlands, in July 2020.
The sponsor’s address was updated in August 2021.
Treatment of gastrointestinal stromal tumours
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Review of designation
Documents related to this orphan designation evaluation
EU/3/17/1936: Public summary of opinion on orphan designation: 1-[4-Bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea for the treatment of gastrointestinal stromal tum... (PDF/126.97 KB)
First published: 15/01/2018
Last updated: 15/01/2018
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Orphanet, a database containing information on rare diseases, which includes a directory of patients’ organisations registered in Europe.
EU register of orphan medicines
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