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First-in-class targeted mIDH1 inhibitor in cholangiocarcinoma (CCA)1,2

TIBSOVO® (ivosidenib tablets) delivered significant improvements
in progression-free survival (PFS)
 in mIDH1 CCA2

reduction in the risk of disease progression or death
(HR, 0.37 [95% CI, 0.25-0.54]; P<0.0001)2

6-month PFS rate3

12-month PFS rate3

See the data

Safety

The safety of TIBSOVO was evaluated in patients with advanced mIDH1 CCA reflective of that seen in clinical practice2

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A recommended treatment option in advanced cholangiocarcinoma

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommend ivosidenib (TIBSOVO) as a subsequent line treatment option for unresectable or metastatic cholangiocarcinoma with an IDH1 mutation following disease progression4

View practice recommendations
IVO

Convenient, once-daily oral dosing1

View dosing

References: 1. Popovici-Muller J, Lemieux RM, Artin E, et al. Discovery of AG-120 (ivosidenib): a first-in-class mutant IDH1 inhibitor for the treatment of IDH1 mutant cancers. ACS Med Chem Lett. 2018;9(4):300-305. 2. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2022. 3. Data on file. Servier Pharmaceuticals, LLC. 4. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Hepatobiliary Cancers V.2.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed August 12, 2022. To view the most recent and complete version of the guideline, go online to NCCN.org. NCCN 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.

 
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cca-efficacy-modal cca-efficacy-modal

CCA, cholangiocarcinoma; ECOG PS, Eastern Cooperative Oncology Group Performance Status; IDH1, isocitrate dehydrogenase-1; mIDH1, mutated IDH1; NGS, next-generation sequencing; QD, once a day; RECIST, Response Evaluation Criteria in Solid Tumors.

References: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2022. 2. Data on file. Servier Pharmaceuticals LLC. 3. Zhu AX, Macarulla T, Javle MM, et al. JAMA Oncol. 2021;7(11):1669-1677.

cca-efficacy-modal cca-efficacy-modal

CCA, cholangiocarcinoma; ECOG PS, Eastern Cooperative Oncology Group Performance Status; IDH1, isocitrate dehydrogenase-1; mIDH1, mutated IDH1; NGS, next-generation sequencing; QD, once a day; RECIST, Response Evaluation Criteria in Solid Tumors.

References: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2022. 2. Data on file. Servier Pharmaceuticals LLC. 3. Zhu AX, Macarulla T, Javle MM, et al. JAMA Oncol. 2021;7(11):1669-1677.

 

Indications & Important Safety Information

INDICATION

TIBSOVO is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for patients with a susceptible IDH1 mutation as detected by an FDA-approved test for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma who have been previously treated.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

QTc Interval Prolongation: Patients treated with TIBSOVO can develop QT (QTc) prolongation and ventricular arrhythmias. Concomitant use of TIBSOVO with drugs known to prolong the QTc interval (eg, anti-arrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) and CYP3A4 inhibitors may increase the risk of QTc interval prolongation. Conduct monitoring of electrocardiograms (ECGs) and electrolytes. In patients with congenital long QTc syndrome, congestive heart failure, or electrolyte abnormalities, or in those who are taking medications known to prolong the QTc interval, more frequent monitoring may be necessary. Interrupt TIBSOVO if QTc increases to greater than 480 msec and less than 500 msec. Interrupt and reduce TIBSOVO if QTc increases to greater than 500 msec. Permanently discontinue TIBSOVO in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.