NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend ivosidenib (TIBSOVO®) for newly diagnoseda and R/R AML with an IDH1 mutation1
aAt least 60 years and not eligible for or declines intensive remission induction therapy. See NCCN Guidelines® for full recommendation.
EFFICACY
TIBSOVO demonstrated strong and durable responses in a patient population with difficult-to-treat disease2,3

Learn more about the efficacy in IC-ineligible patients with newly diagnosed AML

Learn more about
the efficacy in patients
with R/R AML

SAFETY
The safety of TIBSOVO was evaluated in a patient population with difficult-to-treat disease2

BOXED WARNING: Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal if not treated. TIBSOVO is associated with the following Warnings and Precautions: differentiation syndrome, QTc prolongation, and Guillain-Barré syndrome.

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CR, complete remission, defined as <5% blasts in the bone marrow, no evidence of disease, and full recovery of peripheral blood counts (platelets >100,000/microliter and absolute neutrophil counts >1000/microliter); CRh, complete remission with partial hematological recovery, defined as <5% blasts in the bone marrow, no evidence of disease, and partial recovery of peripheral blood counts (platelets >50,000/microliter and absolute neutrophil counts >500/microliter); NCCN®, National Comprehensive Cancer Network®; IC, intensive chemotherapy; RBC, red blood cell; R/R, relapsed or refractory.2

References: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.3.2019. © National Comprehensive Cancer Network, Inc. 2019. All rights reserved. Accessed June 3, 2019. 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. TIBSOVO [package insert]. Cambridge, MA: Agios Pharmaceuticals, Inc.; 2019. 3. Data on file. Agios Pharmaceuticals, Inc.
 

INDICATIONS

TIBSOVO is indicated for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test in:

  • Adult patients with newly diagnosed AML who are ≥75 years old or who have comorbidities that preclude use of intensive induction chemotherapy.
Indications & 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.