MORE THAN THREEFOLD IMPROVEMENT IN mOS1,4,a,b
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
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
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
Learn moreA 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
Learn moreFIRST-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
STRAIGHTFORWARD
DOSING REGIMEN
TIBSOVO offers a straightforward dosing regimen with no titration needed1