Tibsovo® (ivosidenib) – Expanded indication
May 2, 2019 - Agios Pharmaceuticals announced the FDA approval of Tibsovo (ivosidenib), for the treatment of newly-diagnosed acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in adult patients who are ≥ 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
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