Daurismo (glasdegib) vs Ezharmia (valemetostat tosilate)

Daurismo (glasdegib) vs Ezharmia (valemetostat tosilate)

Daurismo (glasdegib) is a targeted therapy approved by the FDA for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients aged 75 years or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. It works by inhibiting the smoothened (SMO) receptor, which is part of the Hedgehog signaling pathway implicated in the development of certain cancers. In contrast, Ezharmia (valemetostat tosilate) is an investigational, selective inhibitor of the EZH1 and EZH2 methyltransferase, which are part of the epigenetic regulation mechanisms involved in various malignancies, and as of the knowledge cutoff date, it has not been approved for use; therefore, its safety and efficacy profiles are not yet fully established. Individuals should consult with their healthcare provider to determine the most appropriate treatment option based on their specific medical condition, overall health, and treatment goals.

Difference between Daurismo and Ezharmia

Metric Daurismo (glasdegib) Ezharmia (valemetostat tosilate)
Generic name Glasdegib Valemetostat tosilate
Indications Acute myeloid leukemia (AML) T-cell lymphoma (under investigation)
Mechanism of action Hedgehog pathway inhibitor EZH1/2 dual inhibitor
Brand names Daurismo Ezharmia (not yet approved, as of the last update)
Administrative route Oral Oral (expected)
Side effects Anemia, fatigue, bleeding, febrile neutropenia, muscle pain, etc. Not fully characterized, under investigation
Contraindications Hypersensitivity to glasdegib or any component of the formulation Not fully established, under investigation
Drug class Hedgehog pathway inhibitor EZH inhibitor
Manufacturer Pfizer Daiichi Sankyo

Efficacy

Efficacy of Daurismo (Glasdegib) in Leukemia Treatment

Daurismo, also known by its generic name glasdegib, is a medication approved by the U.S. Food and Drug Administration (FDA) for the treatment of newly-diagnosed acute myeloid leukemia (AML) in adult patients who are 75 years of age or older, or who have comorbidities that preclude the use of intensive induction chemotherapy. Glasdegib is used in combination with low-dose cytarabine (LDAC), a type of chemotherapy. Clinical trials have demonstrated that the combination of glasdegib with LDAC can lead to an improvement in overall survival compared to LDAC alone. The efficacy of Daurismo in leukemia treatment is attributed to its mechanism of action, which involves inhibiting the Hedgehog signaling pathway, a pathway known to be involved in the proliferation of cancer cells.

In a pivotal phase 2 clinical trial, patients receiving the combination of glasdegib and LDAC had a median overall survival of 8.3 months compared to 4.3 months for patients treated with LDAC alone. This significant improvement in survival outcomes highlights the potential benefit of adding glasdegib to the treatment regimen for older patients with AML or those who cannot tolerate more intensive chemotherapy.

Efficacy of Valemetostat Tosilate (Ezharmia) in Leukemia Treatment

Valemetostat tosilate, known by the brand name Ezharmia, is an investigational drug that is not yet approved for use in the treatment of leukemia or any other condition as of the knowledge cutoff date. Valemetostat tosilate is an enhancer of zeste homolog 2 (EZH2) and DOT1-like histone lysine methyltransferase (DOT1L) dual inhibitor. These enzymes play a role in the epigenetic regulation of gene expression and are implicated in the pathogenesis of various hematologic malignancies, including leukemia.

While valemetostat tosilate has shown promise in early clinical trials, it is important to note that its efficacy and safety profile are still being evaluated. Preliminary data from phase 1/2 studies suggest that valemetostat tosilate may have activity in treating adult patients with relapsed or refractory acute leukemia, including AML and acute lymphoblastic leukemia (ALL). However, further research is necessary to fully establish the therapeutic potential of valemetostat tosilate in leukemia treatment. As an investigational drug, its use is currently limited to clinical trials, and it is not available on the market for general use.

Regulatory Agency Approvals

Daurismo
  • European Medical Agency (EMA), European Union
  • Food and Drug Administration (FDA), USA
  • Health Canada
Ezharmia
  • Pharmaceuticals and Medical Devices Agency (PMDA), Japan

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If Daurismo or Ezharmia are not approved or available in your country (e.g. due to supply issues), you can access them via Everyone.org.

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