EU/3/17/1936: Orphan designation for the treatment of gastrointestinal stromal tumours

1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea

Overview

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.

Key facts

Active substance
1-[4-bromo-5-[1-ethyl-7-(methylamino)-2-oxo-1,2-dihydro-1,6-naphthyridin-3-yl]-2-fluorophenyl]-3-phenylurea
Intented use
Treatment of gastrointestinal stromal tumours
Orphan designation status
Positive
EU designation number
EU/3/17/1936
Date of designation
12/10/2017
Sponsor

Deciphera Pharmaceuticals (Netherlands) B.V.
Atrium Building Floor 4th
Strawinskylaan 3051
Amsterdam
Noord-Holland
1077 ZX
Netherlands
Tel: +31 20 301 2200
E-mail: regulatory@deciphera.com

 

Review of designation

The Committee for Orphan Medicinal Products reviews the orphan designation of a product if it is approved for marketing authorisation.

Documents related to this orphan designation evaluation

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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