Take aim with TIBSOVO®, THE FIRST TARGETED THERAPY OPTION THAT IS AN IDH1 MUTATION INHIBITOR*.
*Comparative clinical significance is unknown.
Indications
- TIBSOVO® (ivosidenib) in combination with azacitidine is indicated for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) with an isocitrate dehydrogenase-1 (IDH1) R132 mutation who are not eligible to receive intensive induction chemotherapy.
- TIBSOVO® is indicated as monotherapy for the treatment of adult patients with locally advanced or metastatic cholangiocarcinoma (CCA) with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
Documentation of an IDH1 R132 mutation using an appropriate diagnostic test is required prior to treatment with TIBSOVO®.
TIBSOVO®: the first targeted therapy in Canada* for management of:
- Newly diagnosed AML with an IDH1 (R132) mutation (in combination with azacitidine) in adults who are not eligible to receive intensive induction chemotherapy
- Locally advanced or metastatic CCA with an IDH1 (R132) mutation (as monotherapy) in adults who were previously treated by at least one prior line of systemic therapy
*Comparative clinical significance has not been established.
TIBSOVO® in AML: A new option for newly diagnosed AML (in combination with azacitidine) in adult patients with an IDH1 (R132) mutation who are ineligible for intensive induction chemotherapy.
TIBSOVO® in CCA: The first targeted therapy option* as monotherapy for patients with locally advanced or metastatic CCA with an IDH1 R132 mutation who were previously treated by at least one prior line of systemic therapy.
Ivosidenib in the NCCN AML Guidelines
Ivosidenib + azacitidine as a preferred treatment option for newly diagnosed patients ≥18 years of age with mIDH1 AML who are not candidates for intensive remission induction therapy (Category 1 recommendation).3
Ivosidenib in the NCCN CCA Guidelines
Ivosidenib in unresectable or metastatic CCA with an IDH1 mutation, as a subsequent-line therapy following disease progression after primary systemic therapy (Category 1 recommendation).4
Consult the TIBSOVO® Product Monograph
2-HG: 2-hydroxyglutarate; α-KG: alpha-ketoglutarate; AML: acute myeloid leukemia; AZA: azacitidine; PBO: placebo; CCA: cholangiocarcinoma; CI: confidence interval; CR: complete response; CRh: complete response with partial hematologic recovery; CTCAE: Common Terminology Criteria for Adverse Events; DLCO: diffusing capacity for carbon monoxide; ECG: electrocardiogram; ECOG PS: Eastern Cooperative Oncology Group Performance Status; EFS: event-free survival; eGFR: estimated glomerular filtration rate; FEV1: forced expiratory volume in 1 second; HR: hazard ratio; IDH1: isocitrate dehydrogenase-1; IRC: Independent Radiology Centre; IV: intravenous; mIDH1: mutated isocitrate dehydrogenase-1; MOA: mechanism of action; NCCN: National Comprehensive Cancer Network; OR: odds ratio; OS: overall survival; PBO: placebo; PCR: polymerase chain reaction; PD: pharmacodynamics; PK: pharmacokinetics; QD: daily; RECIST: Response Evaluation Criteria In Solid Tumors; SC: subcutaneous.
References:
- TIBSOVO® Product Monograph. Servier Canada. July 19, 2024.
- Montesinos P, et al. N Engl J Med. 2022 Apr 21;386(16):1519–1531.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Acute Myeloid Leukemia Version 2.2025 — January 27, 2025.
- National Comprehensive Cancer Network. NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Biliary Duct Cancers Version 6.2024 — January 10, 2025.
- Abou-Alfa GK, et al. Lancet Oncol. 2020 Jun;21(6):796-807.
- Zhu AX, et al. JAMA Oncol. 2021 Nov 1;7(11):1669-1677.
- Dammacco F, Silvestris F, eds. Oncogenomics: From Basic Research to Precision Medicine. Academic Press; 2019.
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