NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend ivosidenib (TIBSOVO®) in R/R AML with an IDH1 mutation1

Both NCCN Guidelines® and ASH-CAP guidelines recommend testing for IDH1 mutations in patients with AML1,2

IDH1 mutations occur in 6% to 10% of patients with AML3

Test at diagnosis and relapse to identify IDH1 mutations4

  • IDH1 mutations were identified by a local or central diagnostic test and confirmed retrospectively using the Abbott RealTime™ IDH1 Assay, which is the FDA-approved test for selection of patients with R/R AML for treatment with TIBSOVO
  • For more information, visit http://www.fda.gov/CompanionDiagnostics
ASH, American Society of Hematology; CAP, College of American Pathologists; NCCN, National Comprehensive Cancer Network® .

TIBSOVO is a first-in-class, oral, noncytotoxic agent that targets the mutant IDH1 enzyme in R/R AML4,5

Differentiation Blocked, Chart Differentiation Restored with TIBSOVO®, Chart
  • In blood samples from patients with AML with mutated IDH1, ivosidenib decreased 2-hydroxyglutarate (2-HG) levels ex-vivo, reduced blast counts, and increased percentages of mature myeloid cells4
  • Ivosidenib was shown to inhibit selected IDH1 R132 mutants at much lower concentrations than wild-type IDH1 in vitro4
  • Susceptible IDH1 mutations are defined as those leading to increased levels of 2-HG in the leukemia cells and where efficacy is predicted by 1) clinically meaningful remissions with the recommended dose of ivosidenib and/or 2) inhibition of mutant IDH1 enzymatic activity at concentrations of ivosidenib sustainable at the recommended dosage according to validated methods4
    • Susceptible IDH1 mutations are R132H, R132C, R132G, R132S, and R132L4
References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines® ) for Acute Myeloid Leukemia V.2.2018. © National Comprehensive Cancer Network, Inc. 2018. All rights reserved. Accessed October 15, 2018. To view the most recent and complete version of the guidelines, go online to NCCN.org. The National Comprehensive Cancer Network makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way. 2. Arber DA, Borowitz MJ, Cessna M, et al. Initial diagnostic workup of acute leukemia: guideline from the College of American Pathologists and the American Society of Hematology. Arch Pathol Lab Med. 2017;141(10):1342-1393. 3. Stone RM, Choe S, Zhang V, et al. Genetic profiling and deep IDH1 mutation clearance to ≤0.04% in ivosidenib (AG-120)-treated patients with mutant IDH1 relapsed or refractory and untreated AML. Poster presented at: 59th American Society of Hematology Annual Meeting; December 9-12, 2017; Atlanta, GA. Poster 2684. 4. TIBSOVO [package insert]. Cambridge, MA: Agios Pharmaceuticals, Inc.; 2018. 5. Data on file. Agios Pharmaceuticals, Inc.
 
 

INDICATION

TIBSOVO® (ivosidenib) 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.

Indication & Important Safety Information

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME

Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.