Tibsovo (ivosidenib) vs Vanflyta (quizartinib)

Tibsovo (ivosidenib) is an oral medication approved for the treatment of acute myeloid leukemia (AML) with a specific genetic mutation known as isocitrate dehydrogenase-1 (IDH1). It works by inhibiting the IDH1 enzyme, which is involved in the abnormal proliferation of leukemic cells. In contrast, Vanflyta (quizartinib) is an oral inhibitor targeting the FLT3 gene mutations in AML, which are another driver of this type of cancer; it is designed to inhibit the FLT3-ITD (internal tandem duplication) positive AML, which is associated with a poor prognosis. When deciding between these medications, it is crucial to determine the specific genetic mutations present in the AML cells, as this will guide the choice of targeted therapy.

Difference between Tibsovo and Vanflyta

Metric	Tibsovo (ivosidenib)	Vanflyta (quizartinib)
Generic name	Ivosidenib	Quizartinib
Indications	Acute Myeloid Leukemia (AML) with a specific mutation (IDH1)	Relapsed or Refractory Acute Myeloid Leukemia (AML) with FLT3-ITD mutations
Mechanism of action	Inhibits mutant IDH1 enzyme, leading to decreased production of the oncometabolite 2-HG and promoting myeloid differentiation	Inhibits FLT3 (FMS-like tyrosine kinase 3), which is a common driver mutation in AML, thereby reducing proliferation of leukemic cells
Brand names	Tibsovo	Vanflyta
Administrative route	Oral	Oral
Side effects	Fatigue, joint pain, diarrhea, dyspnea, edema, rash, nausea, fever, cough, constipation	QT interval prolongation, nausea, thrombocytopenia, musculoskeletal pain, vomiting, fatigue, diarrhea, febrile neutropenia
Contraindications	Hypersensitivity to ivosidenib or any of the excipients	Hypersensitivity to quizartinib or any of its excipients
Drug class	Isocitrate dehydrogenase-1 (IDH1) inhibitor	Tyrosine kinase inhibitor
Manufacturer	Agios Pharmaceuticals, Inc.	Daiichi Sankyo Company, Limited

Efficacy

Efficacy of Tibsovo (Ivosidenib) in Treating Leukemia

Tibsovo, also known by its generic name ivosidenib, is a medication specifically approved for the treatment of acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. This mutation is present in a subset of AML patients. The efficacy of Tibsovo for this indication was demonstrated in a clinical trial where patients with relapsed or refractory AML with an IDH1 mutation were treated with ivosidenib. Results showed a significant percentage of patients achieved complete remission (CR) or complete remission with partial hematologic recovery (CRh), indicating a reduction in disease symptoms and a decrease in the need for transfusions.

The approval of Tibsovo was based on the rate of CR+CRh, the duration of these responses, and the rate of conversion from transfusion dependence to independence. The trial data provided evidence that Tibsovo can induce a meaningful remission in a proportion of patients, with some achieving a level of response that allows them to proceed to potentially curative treatments such as stem cell transplantation. However, it is important to note that the responses vary among individuals, and not all patients with IDH1-mutated AML may benefit from Tibsovo.

Efficacy of Vanflyta (Quizartinib) in Treating Leukemia

Vanflyta, with the generic name quizartinib, is a tyrosine kinase inhibitor that targets FLT3 (FMS-like tyrosine kinase 3) mutations. FLT3 mutations are one of the most common genetic abnormalities in AML. Quizartinib has shown efficacy in clinical trials for patients with relapsed or refractory AML who have the FLT3-ITD mutation. The efficacy of Vanflyta was measured in terms of the overall survival rate, the rate of complete remission with full or partial recovery of blood counts (CR/CRh), and the duration of these remissions.

In a pivotal phase 3 trial, patients receiving quizartinib had a median overall survival that was significantly longer than those receiving salvage chemotherapy. Additionally, a higher percentage of patients treated with Vanflyta achieved complete remission, suggesting that quizartinib can provide a meaningful clinical benefit in this patient population. However, it is important to recognize that quizartinib is not a cure for AML, and the management of the disease often requires a comprehensive approach, including other forms of therapy and supportive care.

Regulatory Agency Approvals

Tibsovo

European Medical Agency (EMA), European Union
Food and Drug Administration (FDA), USA

Vanflyta

European Medical Agency (EMA), European Union
Food and Drug Administration (FDA), USA

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