Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that IDH1 p.R132H status confers therapeutic sensitivity to Azacitidine, Ivosidenib in patients with Acute Myeloid Leukemia.
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.
This statement is based on a regulatory approval from the Food and Drug Administration:
TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test with in combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.