Tibsovo (ivosidenib) vs Elzonris (tagraxofusp-erzs)

Tibsovo (ivosidenib) is an oral medication specifically approved for the treatment of adults with acute myeloid leukemia (AML) that exhibits a particular genetic mutation known as IDH1, as well as for cholangiocarcinoma with an IDH1 mutation. Elzonris (tagraxofusp-erzs), on the other hand, is an intravenous fusion protein directed against the interleukin-3 receptor (CD123) and is used for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), a rare and aggressive form of blood cancer. When deciding between the two, it is essential to consider the specific type of cancer and its genetic profile, as each medication targets different mechanisms and is approved for different indications, thus a healthcare provider should be consulted to determine which medicine is appropriate based on the individual's diagnosis and genetic markers.

Difference between Tibsovo and Elzonris

Metric	Tibsovo (ivosidenib)	Elzonris (tagraxofusp-erzs)
Generic name	Ivosidenib	Tagraxofusp-erzs
Indications	Acute myeloid leukemia (AML) with a specific genetic mutation (IDH1)	Blastic plasmacytoid dendritic cell neoplasm (BPDCN)
Mechanism of action	Inhibits mutated IDH1 enzyme, leading to decreased production of the oncometabolite 2-HG	Fusion protein that targets CD123 and delivers a diphtheria toxin to the cells
Brand names	Tibsovo	Elzonris
Administrative route	Oral	Intravenous
Side effects	Fatigue, leukocytosis, arthralgia, diarrhea, dyspnea, edema, nausea, mucositis, QT prolongation, rash, fever, cough, constipation	Capillary leak syndrome, nausea, fatigue, peripheral edema, pyrexia, weight increase, chills, hypotension
Contraindications	Hypersensitivity to ivosidenib or any of the excipients	Hypersensitivity to tagraxofusp-erzs or any of its components
Drug class	Isocitrate dehydrogenase-1 (IDH1) inhibitor	CD123-directed cytotoxin
Manufacturer	Agios Pharmaceuticals, Inc.	Stemline Therapeutics, Inc.

Efficacy

Efficacy of Tibsovo (Ivosidenib) in Leukemia

Tibsovo (ivosidenib) is an oral medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of acute myeloid leukemia (AML) with a specific genetic mutation known as isocitrate dehydrogenase-1 (IDH1). The efficacy of Tibsovo in treating AML was demonstrated in a clinical trial involving patients with IDH1-mutated relapsed or refractory AML. The trial showed that Tibsovo induced a complete remission (CR) or complete remission with partial hematologic recovery (CRi) in a significant proportion of patients. The median duration of CR+CRi was also notable, suggesting that Tibsovo can lead to a meaningful remission in a subset of patients with this challenging form of leukemia.

The approval of Tibsovo for AML was based on the rate of CR+CRi and the duration of these responses. Patients treated with Tibsovo have shown improvements in survival rates compared to historical outcomes in patients with IDH1-mutated AML. However, it is important to note that the efficacy may vary based on the individual patient's disease characteristics and mutation status.

Efficacy of Elzonris (Tagraxofusp-erzs) in Leukemia

Elzonris (tagraxofusp-erzs) is a targeted therapy approved by the FDA for the treatment of blastic plasmacytoid dendritic cell neoplasm (BPDCN), which is a rare form of leukemia. The efficacy of Elzonris was evaluated in a multi-cohort, open-label clinical trial that included patients with untreated and relapsed or refractory BPDCN. The results from the trial showed that Elzonris achieved a high rate of clinical responses, including complete responses (CR) and clinical benefit in a significant number of patients.

The approval of Elzonris for BPDCN was particularly noteworthy due to the lack of previous FDA-approved therapies specifically for this rare and aggressive form of leukemia. The treatment with Elzonris has provided a new option for patients with BPDCN, and the observed response rates in the clinical trial have indicated a positive impact on disease outcomes. As with any therapy, the response to Elzonris can vary among individuals, and continued research is important to further understand its long-term efficacy and potential in other settings.

Regulatory Agency Approvals

Tibsovo

Food and Drug Administration (FDA), USA

Elzonris

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

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