EU/3/19/2146

About

This medicine is now known as futibatinib.

On 1 April 2019 orphan designation (EU/3/19/2146) was granted by the European Commission to Taiho Pharma Europe Limited, United Kingdom, for 1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]-1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]-2-propen-1-one (also known as TAS-120) for the treatment of biliary tract cancer.

The sponsorship was transferred to Taiho Oncology Europe B.V., Netherlands, in September 2020.

Key facts

Active substance
1-[(3S)-3-{4-amino-3-[(3,5-dimethoxyphenyl)ethynyl]-1H-pyrazolo[3,4-d]pyrimidin-1-yl}pyrrolidin-1-yl]-2-propen-1-one (futibatinib)
Disease / condition
Treatment of biliary tract cancer
Date of first decision
01/04/2019
Outcome
Positive
EU designation number
EU/3/19/2146

Review of designation

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

Sponsor's contact details

Taiho Oncology Europe B.V.
Boulevard 359
1118 BJ Schiphol
Noord-Holland
Netherlands
Tel. +31 20 238 2407
E-mail: makenny@taihooncology.com

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.

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