Tibsovo: Withdrawal of the marketing authorisation application



Agios Netherlands B.V. withdrew its application for a marketing authorisation of Tibsovo for the treatment of acute myeloid leukaemia (AML), a cancer of white blood cells.

The company withdrew the application on 13 October 2020.

Key facts

Product number
International non-proprietary name (INN) or common name
  • ivosidenib
Active substance
  • Ivosidenib
Date of withdrawal
Company making the application
Agios Netherlands B.V.
Withdrawal type
Initial authorisation

Related content

Related information on withdrawals

A question-and-answer (Q&A) document provides a summary of the CHMP's evaluation of the medicine at the time of the withdrawal of the application, and includes a link to the company's formal withdrawal letter.

An assessment report is published when the application is withdrawn after the first stage of the CHMP's evaluation is completed ('day 120').

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