Tibsovo (ivosidenib)
- Region
- 🇪🇺 EU
- Active substance
- ivosidenib
- Company
- Les Laboratoires Servier
- Status
- Authorised
- Therapeutic area
- Leukemia, Myeloid, Acute; Cholangiocarcinoma
- CHMP opinion
- Thu 23 Feb 2023
- EU approval
- Thu 04 May 2023
- Designations
- Orphan, Additional monitoring
- Application
- EMEA/H/C/005936
- ATC
- L01XM02
- Official record
- www.ema.europa.eu
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.
Regulatory milestones
No milestones recorded in the last year.
Same substance in other markets
- 🇪🇺 Tidhesco Application withdrawn · Les Laboratoires Servier
- 🇪🇺 Tibsovo Application withdrawn · Agios Netherlands B.V.
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Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.