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    Association details:
    Biomarker:No biomarker
    Cancer:Acute Myelogenous Leukemia
    Drug:Onureg (azacitidine oral) (DNMT inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Bristol-Myers Squibb Press Release
    Title:

    Bristol Myers Squibb Receives European Commission Approval for Onureg® (azacitidine tablets) as Frontline Oral Maintenance Therapy for Adults with Acute Myeloid Leukemia

    Published date:
    06/18/2021
    Excerpt:
    Bristol Myers Squibb...today announced that the European Commission (EC) has granted full Marketing Authorization for Onureg® (azacitidine tablets) as a maintenance therapy in adult patients with acute myeloid leukemia (AML)...Onureg is the first and only once-daily, frontline oral maintenance therapy to demonstrate significant overall survival and show a relapse-free survival benefit in patients with a broad range of AML subtypes.
    Trial ID:
    QUAZAR AML-001
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    04/24/2021
    Excerpt:
    Onureg is indicated as maintenance therapy in adult patients with acute myeloid leukaemia (AML)...
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    PRNewswire
    Title:

    Health Canada Approves ONUREG (azacitidine tablets), First Maintenance Therapy for Patients in Remission from Acute Myeloid Leukemia Français

    Published date:
    01/12/2021
    Excerpt:
    Bristol Myers Squibb Canada (BMS) announced today that Health Canada has approved ONUREG (azacitidine tablets) for use as the first and only maintenance therapy for adult patients with acute myeloid leukemia (AML)...
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    09/01/2020
    Excerpt:
    ONUREG is a nucleoside metabolic inhibitor indicated for continued treatment of adult patients with acute myeloid leukemia who achieved first complete remission (CR) or complete remission with incomplete blood count recovery (CRi) following intensive induction chemotherapy and are not able to complete intensive curative therapy.
    Trial ID:
    QUAZAR AML-001
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Bristol-Myers Squibb Press Release
    Title:

    Bristol Myers Squibb Receives Positive CHMP Opinion for Onureg (azacitidine tablets; CC-486) as Frontline Oral Maintenance Therapy for Adults with Acute Myeloid Leukemia in First Remission

    Published date:
    04/23/2021
    Excerpt:
    Bristol Myers Squibb...announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Onureg (azacitidine tablets; CC-486) as a maintenance therapy in adult patients with acute myeloid leukemia (AML)...The CHMP adopted a positive opinion based on results from the QUAZAR AML-001 study, a Phase 3, international, randomized, double-blind trial.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Blood
    Title:

    The QUAZAR AML-001 Maintenance Trial: Results of a Phase III International, Randomized, Double-Blind, Placebo-Controlled Study of CC-486 (Oral Formulation of Azacitidine) in Patients with Acute Myeloid Leukemia (AML) in First Remission

    Published date:
    11/21/2019
    Excerpt:
    CC-486 is the first therapy used in the maintenance setting to provide statistically significant and clinically meaningful improvements in both OS and RFS in pts with AML in remission following induction chemotherapy, with or without consolidation.
    DOI:
    10.1182/blood-2019-132405
    Trial ID:
    QUAZAR AML-001