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TIBSOVO® (ivosidenib tablets) is the first-in-class mIDH1 inhibitor FDA-approved to treat R/R MDS

Explore the data

a CR was defined as bone marrow ≤5% myeloblasts with normal maturation of all cell lines, hemoglobin ≥11 g/dL, platelets ≥100 x 109/L, neutrophils ≥1.0 x 109/L, and response lasting at least 4 weeks.2 43% of CR responders had baseline bone marrow blasts <5%.1

b Six out of 9 patients who were transfusion-dependent at baseline achieved transfusion independence.1 Postbaseline transfusion independence was defined as a period of ≥56 days with no red blood cell and/or platelet transfusions after the start of study treatment and on or before the end of study treatment.2

First AND ONLY mIDH1 INHIBITOR FOR R/R MDS1,3

TIBSOVO HAS STRONG EFFICACY DATA IN R/R MDS

39%
39% of patients achieved CRa with TIBSOVO (95% CI, 17.3-64.3)1
Median DOCR was not reached by data cutoff (range, 1.9, 80.8+ months; 95% CI, 1.9-NE)1,2,b
67% transfusion independence in patients who were transfusion-dependent at baseline1,c
35.7 months
Median OS was estimated to be 35.7 months
(95% CI, 13.1-NE)2,d
Because there was no control arm in this study, OS results should be interpreted cautiously.1
More efficacy

aCR was defined as bone marrow ≤5% myeloblasts with normal maturation of all cell lines, hemoglobin ≥11 g/dL, platelets ≥100 x 109/L, neutrophils ≥1.0 x 109/L, and response lasting at least 4 weeks.2 43% of CR responders had baseline bone marrow blasts <5%.1

bDOCR was derived based on Kaplan-Meier method and is the date of the first documented CR (lasting ≥4 weeks) to the date of the first documented relapse or death, whichever was earlier.1 Plus sign (+) indicates a censored observation.

cSix out of 9 patients who were transfusion-dependent at baseline achieved transfusion independence.1 Postbaseline transfusion independence was defined as a period of ≥56 days with no red blood cell and/or platelet transfusions after the start of study treatment and on or before the end of study treatment.2

dMedian OS follow-up was 27.1 months.2

DOCR, duration of CR; mIDH1, mutated isocitrate dehydrogenase-1; NE, not estimable; OS, overall survival; R/R, relapsed or refractory.

IDH1 MUTATIONS ARE EARLY DRIVERS IN MDS PROGRESSION4,5

  • IDH1 mutations can arise anytime during the course of MDS and can occur in up to 4% of patients and the mutation rate may double in patients who progress to AML6,7
    • Up to 40% of MDS patients progress to AML8
    • Progression to AML occurs more frequently and rapidly in patients with high-risk MDS8
  • Retest your patients for IDH1 mutations at the first suspicion of clinical change7
  • Consider TIBSOVO for patients with mIDH1 MDS experiencing their first relapse1
NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommends ivosidenib (TIBSOVO) as a targeted treatment option for certain patients with refractory MDS with IDH1 mutations.9,a
Learn more

aCategory 2A recommendation for lower-risk disease, including for patients with symptomatic anemia, and higher-risk disease.9

AML, acute myeloid leukemia; IDH1, isocitrate dehydrogenase-1; mIDH1, mutated IDH1; NCCN, National Comprehensive Cancer Network® (NCCN®).

CLASSIFICATION SYSTEMS ARE EVOLVING10

  • Clinical classifications systems continue to evolve to de-emphasize morphologic features and fixed blast cutoffs in distinguishing MDS from AML10
  • Updated 2022 WHO and ICC guidelines focus heavily on molecular and genetic features when characterizing MDS and AML10

Consider how updated classifications may impact how your patients are diagnosed and managed.11,12

Learn more

AML, acute myeloid leukemia; ICC, International Consensus Classification; WHO, World Health Organization.

Number One Prescribed mIDH1 Inhibitor

TIBSOVO IS THE FIRST-IN-CLASS mIDH1 INHIBITOR WITH OVER 6 YEARS OF EXPERIENCE1,13

References: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2023. 2. Data on file. Servier Pharmaceuticals LLC. 3. Servier announces FDA approval of TIBSOVO® (ivosidenib tablets) for the treatment of IDH1-mutated relapsed or refractory (R/R) myelodysplastic syndromes (MDS). Servier Pharmaceuticals LLC. Published October 24, 2023. Accessed March 16, 2024. https://servier.us/blog/servier-announces-fda-approval-of-tibsovo-ivosidenib-tablets-for-the-treatment-of-idh1-mutated-relapsed-or-refractory-r-r-myelodysplastic-syndromes-mds/ 4. Guess T, Potts CR, Bhat P, et al. Distinct patterns of clonal evolution drive myelodysplastic syndrome progression to secondary acute myeloid leukemia. Blood Cancer Discov. 2022;3(4):316-329. doi:10.1158/2643-3230.BCD-21-0128 5. DiNardo CD, Jabbour E, Ravandi F, et al. IDH1 and IDH2 mutations in myelodysplastic syndromes and role in disease progression. Leukemia. 2016;30(4):980-984. doi:10.1038/leu.2015.211 6. Thol F, Weissinger EM, Krauter J, et al. IDH1 mutations in patients with myelodysplastic syndromes are associated with an unfavorable prognosis. Haematologica. 2010;95(10):1668-1674. doi:10.3324/haematol.2010.025494 7. Platzbecker U, Kubasch AS, Homer-Bouthiette C, Prebet T. Current challenges and unmet medical needs in myelodysplastic syndromes. Leukemia. 2021;35(8):2182-2198. doi:10.1038/s41375-021-01265-7 8. Bănescu C, Tripon F, Muntean C. The genetic landscape of myelodysplastic neoplasm progression to acute myeloid leukemia. Int J Mol Sci. 2023;24(6):5734. doi:10.3390/ijms24065734 9. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Myelodysplastic Syndromes V.1.2024. © National Comprehensive Cancer Network, Inc. 2024. All rights reserved. Accessed February 20, 2024. 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. 10. Falini B, Martelli MP. Comparison of the International Consensus and 5th WHO edition classifications of adult myelodysplastic syndromes and acute myeloid leukemia. Am J Hematol. 2023;98(3):481-492. doi:10.1002/ajh.26812 11. Khoury JD, Solary E, Abla O, et al. The 5th edition of the World Health Organization Classification of Haematolymphoid Tumours: Myeloid and Histiocytic/Dendritic Neoplasms. Leukemia. 2022;36(7):1703-1719. doi:10.1038/s41375-022-01613-1 12. Arber DA, Orazi A, Hasserjian RP, et al. International Consensus Classification of Myeloid Neoplasms and Acute Leukemias: integrating morphologic, clinical, and genomic data. Blood. 2022;140(11):1200-1228. doi:10.1182/blood.2022015850 13. 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. doi:10.1021/acsmedchemlett.7b00421
 

Indication

TIBSOVO is indicated for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes (MDS) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test.

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME IN MDS
Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. 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.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome in MDS: Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal. Symptoms of differentiation syndrome in patients treated with TIBSOVO included noninfectious leukocytosis, peripheral edema, pyrexia, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonitis, pericardial effusion, rash, fluid overload, tumor lysis syndrome, and creatinine increased.

If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. If concomitant noninfectious leukocytosis is observed, initiate treatment with hydroxyurea or leukapheresis, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid and/or hydroxyurea treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt TIBSOVO until signs and symptoms are no longer severe.

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, electrolyte abnormalities, or 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.

Guillain-Barré Syndrome: Guillain-Barré syndrome can develop in patients treated with TIBSOVO. Monitor patients taking TIBSOVO for onset of new signs or symptoms of motor and/or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, paresthesias, or difficulty breathing. Permanently discontinue TIBSOVO in patients who are diagnosed with Guillain-Barré syndrome.

ADVERSE REACTIONS

The most common adverse reactions including laboratory abnormalities (≥25%) in patients with relapsed or refractory MDS are creatinine increased, hemoglobin decreased, arthralgia, albumin decreased, aspartate aminotransferase increased, fatigue, diarrhea, cough, sodium decreased, mucositis, decreased appetite, myalgia, phosphate decreased, pruritus, and rash.

DRUG INTERACTIONS

Strong or Moderate CYP3A4 Inhibitors: Reduce TIBSOVO dose with strong CYP3A4 inhibitors. Monitor patients for increased risk of QTc interval prolongation.

Strong CYP3A4 Inducers: Avoid concomitant use with TIBSOVO.

Sensitive CYP3A4 Substrates: Avoid concomitant use with TIBSOVO.

QTc Prolonging Drugs: Avoid concomitant use with TIBSOVO. If co-administration is unavoidable, monitor patients for increased risk of QTc interval prolongation.

LACTATION

Advise women not to breastfeed.

Please see Full Prescribing Information, including BOXED WARNING for MDS patients.

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INDICATION

TIBSOVO is indicated for the treatment of adult patients with relapsed or refractory myelodysplastic syndromes (MDS) 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 IN MDS

Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. 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.