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    Home > Biochemistry News > Biotechnology News > Extending the Life of AML Patients for the First Time FDA approves the first ongoing treatment.

    Extending the Life of AML Patients for the First Time FDA approves the first ongoing treatment.

    • Last Update: 2020-09-19
    • Source: Internet
    • Author: User
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    Acute myeloid leukemia (AML) is one of the most common acute leukemias in adults.
    is characterized by the rapid growth of abnormal cells in the bone marrow, which interferes with the production and function of normal blood cells.
    can cause symptoms of anemia, bleeding and infection due to damage to red blood cells, plateplates and white blood cell production.
    some AML responses to treatment are short-lived, which means that there is still a very high risk of recurrence after the patient's initial response to chemotherapy.
    Onureg is the first and only AML continuous treatment drug approved by the FDA for patients with remission, an oral low methylation preparation.
    mechanism of action is thought to be low methylation of DNA and direct cytotoxicity to abnormal hematostoid cells in the bone marrow.
    low methylation may restore normal function of genes essential for cell differentiation and proliferation.
    this approval is based on the results of a key Phase 3 clinical trial, QUAZAR®AML-001, in which Onureg therapy resulted in statistically significant and clinically significant improvements in total patient survival (OS) compared to placebos.
    OS was 24.7 months in patients in the Onureg group, while the placebo group was 14.8 months (HR:0.69, 95% CI:0.55-0.86; p=0.0009).
    " in the QUAZAR® AML-001 study, Onureg's ongoing treatment provided survival benefits for adult patients with AML who were first fully relieved.
    It's worth noting that, given that it's a daily oral dosage form, Onureg may make it easier for patients to take the drug," said lead researcher Dr Andrew Wei of Monash University in Australia and lead researcher on the QUAZAR®AML-001 study.
    suitable for adult patients who receive their first complete remission after chemotherapy and are unable to undergo strong healing treatments such as hematocyte transplantation.
    " References: U.S. Food and Drug Administration Approves Onureg® (azacitidine tablets), a New Oral Therapy, as Continued Treatment for Adults in First Remision With Acute Myeloid Leukemia. Retrieved September 1, 2020, from.
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