This medicine is authorised for use in the European Union.


Tibsovo is a cancer medicine used to treat adults with:

  • acute myeloid leukaemia (AML) that is newly diagnosed. For the treatment of AML, the medicine is used in combination with azacitidine (another cancer medicine). The medicine can only be used in patients whose cancer cells have an ‘IDH1 R132 mutation’, a specific mutation (change) in the gene for a protein called isocitrate dehydrogenase-1 (IDH1), and who cannot be treated with standard chemotherapy;
  • biliary tract cancer that is locally advanced (has spread nearby) or metastatic (has spread to other parts of the body). For the treatment of biliary tract cancer, the medicine is used on its own. It can only be used in patients whose cancer has an IDH1 R132 mutation and who have received at least one prior systemic treatment (treatment given by mouth or injection).

These diseases are rare, and Tibsovo was designated an ‘orphan medicine’ (a medicine used in rare diseases). Further information on the orphan designations can be found on the European Medicines Agency’s website (acute myeloid leukaemia: 12 December 2016; biliary tract cancer: 21 March 2018).

Tibsovo contains the active substance ivosidenib.

This EPAR was last updated on 12/05/2023

Authorisation details

Product details
Agency product number
Active substance
International non-proprietary name (INN) or common name
Therapeutic area (MeSH)
  • Leukemia, Myeloid, Acute
  • Cholangiocarcinoma
Anatomical therapeutic chemical (ATC) code
Additional monitoringAdditional monitoring

This medicine is under additional monitoring, meaning that it is monitored even more intensively than other medicines. For more information, see Medicines under additional monitoring.


This medicine was designated an orphan medicine. This means that it was developed for use against a rare, life-threatening or chronically debilitating condition or, for economic reasons, it would be unlikely to have been developed without incentives. For more information, see Orphan designation.

Publication details
Marketing-authorisation holder
Les Laboratoires Servier
Date of issue of marketing authorisation valid throughout the European Union
Contact address

Les Laboratoires Servier
50 rue Carnot
F-92284 Suresnes Cedex

Product information

Tibsovo - EMEA/H/C/005936 -

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You can find product information documents for centrally authorised human medicines on this website. For centrally authorised veterinary medicines authorised or updated from February 2022, see the Veterinary Medicines Information website.

Pharmacotherapeutic group

Antineoplastic agents

Therapeutic indication

Tibsovo in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive standard induction chemotherapy (see section 5.1).

Tibsovo monotherapy is indicated for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.

Assessment history

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