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Now approved FOR PATIENTS WITH R/R MDS

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

Press Release Prescribing Information
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Laser-focused
on survival

TIBSOVO® (ivosidenib tablets) is the first-in-class mIDH1 inhibitor that extends overall survival and delivers strong and durable responses in AML

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a (95% CI, 11.3-34.1) vs 7.9 months
(95% CI, 4.1-11.3) with azacitidine
(HR, 0.44 [95% CI, 0.27-0.73];
P=0.0010)1,2

Discover long-term follow-up data for TIBSOVO + azacitidine
>

MORE THAN THREEFOLD IMPROVEMENT IN mOS1,4,a,b

os_post-asco_2023_combo Chart

aThe data cutoff date of the primary analysis from the AGILE study was March 2021 with a median follow-up of 15.1 months for the OS analysis.1,3

bThe data cutoff date of the long-term follow-up analysis from the AGILE study was June 2022 with a median follow-up of 28.6 months for the OS analysis.4

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STRONG AND DURABLE COMPLETE REMISSION

47% of patients achieved CR on TIBSOVO + azacitidine

(95% CI, 35-59; P<0.0001) vs 15% on azacitidine (95% CI, 8-25)1,a

  • Median duration of CR was not estimable (NE) as of the data cutoff date in the TIBSOVO + azacitidine arm (95% CI, 13.0-NE) and was 11.2 months in the azacitidine arm (95% CI, 3.2-NE)1
  • Of the patients who achieved CR with TIBSOVO + azacitidine, 88% remained in remission at 12 months (95% CI, 67.5-96.2) per Kaplan-Meier estimation2,3
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aCR was defined as <5% blasts in the bone marrow and no Auer rods, absence of extramedullary disease, full recovery of peripheral blood counts (absolute neutrophil count ≥1000/μL and platelets ≥100,000/μL), and independence of red blood cell transfusions.2

SAFETY

TIBSOVO has a well-characterized safety profile studied in more than 270 patients with mIDH1 AML1

BOXED WARNING: Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal. TIBSOVO is associated with the following Warnings and Precautions: differentiation syndrome, QTc prolongation, and Guillain-Barré syndrome.1

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A RECOMMENDED TREATMENT OPTION

NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) recommends ivosidenib (TIBSOVO) + azacitidine as a category 1 preferred treatment option for newly diagnosed patients with mIDH1 who are not candidates for intensive remission induction therapy.5

Discover the importance of IDH1 testing at diagnosis and relapse

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FIRST-IN-CLASS DIFFERENTIATION THERAPY1,6

Single-agent TIBSOVO helps achieve multiple treatment goals for your patients with difficult‑to‑treat mIDH1 AML1

In newly diagnosed,
IC‑ineligible AML

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In
R/R AML

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TIBSOVO is the #1 prescribed mIDH1 inhibitor

TIBSOVO has over 5 years of real-world experience1,2

  • Built on a broad body of evidence studied in over 270 mIDH1 AML patients1
  • More than 2170 AML patients have been treated with TIBSOVO since FDA approval in July 20182

See how TIBSOVO + azacitidine delivers strong and durable results1,3

Explore the data
bottle with two pills

STRAIGHTFORWARD
DOSING REGIMEN

TIBSOVO offers a straightforward dosing regimen with no titration needed1

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RESOURCES

about TIBSOVO for you
and your practice

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Servier One | Home

SUPPORT

with ServierONE Patient Support Services for access and financial assistance

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Early use of TIBSOVO may offer your mIDH1 AML patients the chance for improved outcomes1,2
AZA, azacitidine; CI, confidence interval; CR, complete remission; HR, hazard ratio; IC, induction chemotherapy; mIDH1, mutated isocitrate dehydrogenase‑1; NCCN, National Comprehensive Cancer Network® (NCCN®); OS, overall survival; R/R, relapsed/refractory.

References: 1. Tibsovo. Package insert. Servier Pharmaceuticals LLC; 2023. 2. Data on file. Servier Pharmaceuticals LLC. 3. Montesinos P, Recher C, Vives S, et al. Ivosidenib and azacitidine in IDH1-mutated acute myeloid leukemia. N Engl J Med. 2022;386(16):1519-1531. doi:10.1056/NEJMoa2117344 4. de Botton S, Montesinos P, Vives Polo S, et al. Updated efficacy and safety data from the AGILE study in patients with newly-diagnosed acute myeloid leukemia treated with ivosidenib + azacitidine compared to placebo + azacitidine. Poster presented at: 2023 American Society of Clinical Oncology Annual Meeting; June 2-6, 2023; Chicago, IL. 5. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.4.2023. © National Comprehensive Cancer Network, Inc. 2023. All rights reserved. Accessed July 26, 2023. To view the most recent and complete version of the guideline, go online to NCCN.org. 6. 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
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Indications

TIBSOVO is indicated for patients with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test with:

Newly Diagnosed Acute Myeloid Leukemia (AML)

  • In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy

Relapsed or Refractory AML

  • For the treatment of adult patients with relapsed or refractory AML

Relapsed or Refractory Myelodysplastic Syndromes (MDS)

  • For the treatment of adult patients with relapsed or refractory MDS

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME IN AML AND 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 AML and 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

  • In patients with AML, the most common adverse reactions including laboratory abnormalities (≥25%) are leukocytes decreased, diarrhea, hemoglobin decreased, platelets decreased, glucose increased, fatigue, alkaline phosphatase increased, edema, potassium decreased, nausea, vomiting, phosphate decreased, decreased appetite, sodium decreased, leukocytosis, magnesium decreased, aspartate aminotransferase increased, arthralgia, dyspnea, uric acid increased, abdominal pain, creatinine increased, mucositis, rash, electrocardiogram QT prolonged, differentiation syndrome, calcium decreased, neutrophils decreased, and myalgia
  • In patients with MDS, the most common adverse reactions including laboratory abnormalities (≥25%) 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 AML and MDS patients.

 

INDICATIONS

TIBSOVO is indicated for patients with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test with:

Newly Diagnosed Acute Myeloid Leukemia (AML)

  • In combination with azacitidine or as monotherapy for the treatment of newly diagnosed AML in adults 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy
Indications & Important Safety Information

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME IN AML AND 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.