250 mg
Trade Name
TIBSOVO
Film-coated tablet
Request Type
Registration
Drug Type
New Drug
Approval Date
SFDA Approved Use
Ivosidenib 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 intensive induction chemotherapy.
Ivosidenib 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 prior line of systemic therapy.
Ivosidenib 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 prior line of systemic therapy.