Tibsovo
What Tibsovo is used for
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.
Approved use, as published by the European Medicines Agency.
What the labels mean
- Orphan medicine: for a rare disease (affecting no more than 5 in 10,000 people in the EU).
Key facts
- Brand
- Tibsovo
- Active substance
- ivosidenib
- Disease area
- Leukemia, Myeloid, Acute; Cholangiocarcinoma
- Medicine group
- Antineoplastic agents
- ATC code
- L01XM02
- Marketing authorisation holder
- Les Laboratoires Servier
- Authorised in the EU since
- 2023
Official information
In the USA
Same active substance: Tibsovo
Specialist medicine: started and supervised by a specialist doctor or hospital. This page is a plain-language summary of public official information, not medical advice; follow your doctor and the official product information.
Common questions
What is Tibsovo used for?
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.
What is the active substance in Tibsovo?
Tibsovo contains ivosidenib.
Who makes Tibsovo?
The EU marketing authorisation holder is Les Laboratoires Servier.
Is Tibsovo an orphan medicine?
Yes. Tibsovo is designated an orphan medicine in the EU, for a rare disease (Leukemia, Myeloid, Acute; Cholangiocarcinoma).
Source: European Medicines Agency medicines data (ema.europa.eu), reproduced with acknowledgement of the source. Page made 5 November 2026 by Satya Babu.
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