Tibsovo (ivosidenib) vs Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Tibsovo (ivosidenib) vs Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn)
Tibsovo (ivosidenib) is a targeted therapy specifically designed to inhibit the mutated IDH1 enzyme, often used in the treatment of acute myeloid leukemia (AML) with a susceptible IDH1 mutation. Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn), on the other hand, is an asparagine-specific enzyme used to treat acute lymphoblastic leukemia (ALL) by depleting the amino acid asparagine, which leukemia cells need to survive. The choice between Tibsovo and Rylaze would depend on the specific type of leukemia a patient has and the presence of certain genetic mutations, as these medications are not interchangeable and are used to treat different forms of the disease with distinct mechanisms of action.
Difference between Tibsovo and Rylaze
| Metric | Tibsovo (ivosidenib) | Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) |
|---|---|---|
| Generic name | Ivosidenib | Asparaginase erwinia chrysanthemi (recombinant)-rywn |
| Indications | Acute myeloid leukemia (AML) with a specific genetic mutation (IDH1) | Acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL) in patients who are hypersensitive to E. coli-derived asparaginase |
| Mechanism of action | Inhibits the mutant IDH1 enzyme, leading to decreased production of the oncometabolite 2-hydroxyglutarate (2-HG) | Catalyzes the conversion of the amino acid asparagine into aspartic acid, depleting asparagine levels and inhibiting protein synthesis in leukemic cells |
| Brand names | Tibsovo | Rylaze |
| Administrative route | Oral | Intramuscular or subcutaneous injection |
| Side effects | Fatigue, joint pain, diarrhea, dyspnea, edema, rash, nausea, fever, cough, constipation | Allergic reactions, pancreatitis, thrombosis, hemorrhage, elevated liver enzymes, hyperglycemia |
| Contraindications | Known hypersensitivity to ivosidenib or any of its components | Known hypersensitivity to asparaginase erwinia chrysanthemi or any of its components |
| Drug class | Isocitrate dehydrogenase-1 (IDH1) inhibitor | Asparagine specific enzyme |
| Manufacturer | Agios Pharmaceuticals, Inc. | Jazz Pharmaceuticals, Inc. |
Efficacy
Tibsovo (ivosidenib) Efficacy in Leukemia
Tibsovo (ivosidenib) is an oral medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of certain types of leukemia. Specifically, it is indicated for adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible isocitrate dehydrogenase-1 (IDH1) mutation as detected by an FDA-approved test. The efficacy of Tibsovo was demonstrated in a clinical trial that included patients with relapsed or refractory AML with an IDH1 mutation. In this study, Tibsovo showed a significant improvement in the rate of complete remission (CR) and complete remission with partial hematologic recovery (CRh), providing a therapeutic option for patients with this specific genetic mutation.
The trial's results indicated that the response to Tibsovo was durable, with a median duration of CR+CRh lasting several months. Additionally, some patients were able to undergo a stem cell transplant following treatment with Tibsovo, which is a potentially curative procedure for AML. However, the overall survival benefit of Tibsovo for AML patients with the IDH1 mutation needs further investigation to be fully understood.
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) Efficacy in Leukemia
Rylaze (asparaginase erwinia chrysanthemi (recombinant)-rywn) is an asparagine-specific enzyme indicated as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) and lymphoblastic lymphoma (LBL). It is specifically used in patients who have developed hypersensitivity to E. coli-derived asparaginase. Rylaze has been shown to maintain asparaginase activity levels above the therapeutic threshold, which is critical for the efficacy of treatment in ALL and LBL.
The approval of Rylaze was based on a demonstration of achieving and maintaining nadir serum asparaginase activity above the level of 0.1 U/mL, which is considered necessary for asparagine depletion. Clinical trials have shown that Rylaze effectively sustains this activity level with a dosing schedule that is less frequent than that required by other available formulations. This improved dosing schedule can potentially lead to better patient compliance and a reduced burden of treatment. While Rylaze's direct impact on survival and remission rates in ALL and LBL patients requires additional long-term studies, its ability to maintain therapeutic enzyme levels represents a significant advancement in the management of these patients.
Regulatory Agency Approvals
Tibsovo
-
Food and Drug Administration (FDA), USA
Rylaze
-
Food and Drug Administration (FDA), USA
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