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

The pivotal trial for TIBSOVO was an open-label, single-arm, multicenter trial.2
Click here to learn more about the trial design and patient demographics.


EFFICACY
TIBSOVO demonstrated strong and durable responses in a patient population with difficult-to-treat disease2
33%
of patients (57/174) achieved CR or CRh
(95% CI, 25.8-40.3)2
47.3% of patients who had received 1 prior regimen (35/74) achieved CR or CRh
(95% CI, 35.6-59.3)3
8.2
months
(95% CI, 5.6-12)a
Median duration
of CR+CRh2
37%
of patients who were
transfusion dependent
at baseline
(41/110) became
transfusion independent2b

Patients should remain on TIBSOVO until disease progression or unacceptable toxicity. For patients without disease progression or unacceptable toxicity, treat for a minimum of 6 months to allow time for clinical response.2

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

Serious adverse reactions (≥5%) were differentiation syndrome (10%), leukocytosis (10%), and electrocardiogram QT prolonged (7%). There was one case of progressive multifocal leukoencephalopathy (PML).2

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aDuration of response was defined as time since first response of CR or CRh to relapse or death, whichever is earlier.2
bPatients were defined as transfusion dependent at baseline if they received any transfusion occurring within 56 days prior to the first dose of TIBSOVO. Patients were defined as transfusion independent if they became independent of RBC and platelet transfusions during any 56-day postbaseline period.2
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); 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.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. TIBSOVO [package insert]. Cambridge, MA: Agios Pharmaceuticals, Inc.; 2018. 3. 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.