What is the generic name?

IVOSIDENIB

What is the Trade Name for IVOSIDENIB?

Tibsovo

What are the Indications for IVOSIDENIB?

• 1 INDICATIONS AND USAGE TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test in: Adult patients with newly-diagnosed AML who are ‚â• 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy. ( 1.1 ). Adult patients with relapsed or refractory AML ( 1.2 ). 1.1 Newly-Diagnosed Acute Myeloid Leukemia TIBSOVO is indicated 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 ‚â• 75 years old or who have comorbidities that preclude use of intensive induction chemotherapy [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ) and Clinical Studies ( 14.1 )]. 1.2 Relapsed or Refractory Acute Myeloid Leukemia TIBSOVO is indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test [see Dosage and Administration ( 2.1 ), Clinical Pharmacology ( 12.1 ) and Clinical Studies ( 14.2 )].

References: https://open.fda.gov/