Inqovi (decitabine and cedazuridine) vs Ezharmia (valemetostat tosilate)
Inqovi (decitabine and cedazuridine) vs Ezharmia (valemetostat tosilate)
Inqovi (decitabine and cedazuridine) is an orally administered combination of hypomethylating agents approved for the treatment of adults with myelodysplastic syndromes (MDS), including certain types of chronic myelomonocytic leukemia (CMML). Ezharmia (valemetostat tosilate), on the other hand, is an investigational, orally active EZH1/2 dual inhibitor that is being studied for the treatment of various hematological malignancies and solid tumors, with its safety and efficacy not yet fully established. When deciding between these two medications, it is crucial to consider the specific type of cancer diagnosed, the stage of the disease, the patient's overall health, and to consult with a healthcare provider to determine the most appropriate treatment option based on current clinical guidelines and the availability of the drugs.
Difference between Inqovi and Ezharmia
| Metric | Inqovi (decitabine and cedazuridine) | Ezharmia (valemetostat tosilate) |
|---|---|---|
| Generic name | Decitabine and cedazuridine | Valemetostat tosilate |
| Indications | Myelodysplastic syndromes (MDS), including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes and Intermediate-1, Intermediate-2, and high-risk International Prognostic Scoring System groups | Currently under investigation, potential indication for adult patients with relapsed or refractory peripheral T-cell lymphoma (PTCL) |
| Mechanism of action | Hypomethylating agent; decitabine is incorporated into DNA and inhibits DNA methyltransferase, leading to hypomethylation of DNA. Cedazuridine inhibits cytidine deaminase, which increases the bioavailability of decitabine. | Dual inhibitor of enhancer of zeste homolog 1 and 2 (EZH1 and EZH2), which are histone methyltransferases that can suppress gene expression. |
| Brand names | Inqovi | Ezharmia |
| Administrative route | Oral | Under investigation, likely oral |
| Side effects | Fatigue, constipation, hemorrhage, myalgia, mucositis, arthralgia, nausea, dyspnea, diarrhea, rash, dizziness, febrile neutropenia, edema, headache, cough, decreased appetite, upper respiratory tract infection, pneumonia, and transaminase increased | Not fully characterized; potential side effects include gastrointestinal symptoms, hematological abnormalities, and fatigue |
| Contraindications | Hypersensitivity to decitabine or cedazuridine, or any component of the formulation | Not fully established; likely hypersensitivity to valemetostat tosilate or any component of the formulation |
| Drug class | Hypomethylating agent | Small molecule inhibitor; EZH1/2 inhibitor |
| Manufacturer | Astellas Pharma US, Inc. | Daiichi Sankyo |
Efficacy
Inqovi (decitabine and cedazuridine) for Leukemia
Inqovi, a combination of decitabine and cedazuridine, is an oral hypomethylating agent approved for the treatment of adult patients with myelodysplastic syndromes (MDS), including chronic myelomonocytic leukemia (CMML). MDS are a group of bone marrow disorders that often progress to acute myeloid leukemia (AML). Clinical trials have demonstrated the efficacy of Inqovi in these conditions. In a pivotal phase 3 trial, Inqovi showed similar drug exposure to intravenous decitabine with the convenience of oral administration, which can be significant for patients who require continuous treatment for their condition.
The efficacy of Inqovi was measured in terms of complete remission (CR) rates, hematologic improvement, and overall survival. The results indicated that Inqovi is effective in inducing CR in a significant proportion of patients with MDS and CMML, with the added benefit of reducing the frequency of hospital visits. This is particularly important for leukemia patients who may have compromised immune systems and are at a higher risk of infections.
Ezharmia (valemetostat tosilate) for Leukemia
Ezharmia (valemetostat tosilate) is an investigational agent and has not been approved for any indication as of the knowledge cutoff in 2023. Valemetostat tosilate is an EZH1/2 dual inhibitor that targets the epigenetic regulation of gene expression, which is a mechanism implicated in the pathogenesis of various malignancies, including leukemia. While clinical data may be available from early-phase trials, it is important to note that the efficacy and safety profile of valemetostat tosilate for the treatment of leukemia have not been fully established and are subject to ongoing research.
Given that valemetostat tosilate is still under investigation, any information regarding its efficacy in leukemia should be interpreted with caution and within the context of clinical trials. As with any investigational drug, the potential benefits and risks will need to be thoroughly evaluated through rigorous clinical testing before any conclusions can be drawn about its role in the treatment of leukemia. Patients and healthcare providers should consult current clinical trial data and regulatory updates for the most recent information on the efficacy of valemetostat tosilate for leukemia.
Regulatory Agency Approvals
Inqovi
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Food and Drug Administration (FDA), USA
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Health Canada
Ezharmia
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Pharmaceuticals and Medical Devices Agency (PMDA), Japan
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