Therapeutic Response

IDH1 p.R132L status confers therapeutic sensitivity to Azacitidine in combination with Ivosidenib in patients with Acute Myeloid Leukemia.

Statements

Source and description
Tibsovo (ivosidenib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to ivosidenib as a monotherapy or in combination with azacitidine for the treatment of adult patients newly-diagnosed acute myeloid leukemia (AML) with a susceptible IDH1 mutation, as detected by an FDA-approved test, aged 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
Tibsovo (ivosidenib) [product information]. EMA. The European Medicines Agency (EMA) has authorized ivosidenib in combination with azacitidine 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.