Tibsovo

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](/en/medicines/human/orphan-designations/eu-3-16-1802): 12 December 2016; [biliary tract cancer](/en/medicines/human/orphan-designations/eu-3-18-1994): 21 March 2018). Tibsovo contains the active substance ivosidenib.