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    Association details:
    Biomarker:No biomarker
    Cancer:Acute Myelogenous Leukemia
    Drug:Venclexta (venetoclax) (Bcl2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    AbbVie Press Release
    Title:

    AbbVie Receives European Commission Approval of VENCLYXTO (venetoclax) in Combination with a Hypomethylating Agent for Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

    Published date:
    05/25/2021
    Excerpt:
    AbbVie...announced today that the European Commission (EC) has approved VENCLYXTO (venetoclax) in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy.
    Secondary therapy:
    azacitidine; decitabine
    Trial ID:
    Viale-a
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    AbbVie Press Release
    Title:

    AbbVie Receives European Commission Approval of VENCLYXTO® (venetoclax) in Combination with a Hypomethylating Agent for Patients with Newly Diagnosed Acute Myeloid Leukemia Who Are Ineligible for Intensive Chemotherapy

    Published date:
    05/25/2021
    Excerpt:
    AbbVie...announced today that the European Commission (EC) has approved VENCLYXTO® (venetoclax) in combination with a hypomethylating agent, azacitidine or decitabine, for the treatment of adult patients with newly diagnosed acute myeloid leukemia (AML) who are ineligible for intensive chemotherapy...The VIALE-A trial demonstrated patients who received VENCLYXTO in combination with azacitidine showed statistically significantly greater median overall survival (OS) than patients receiving azacitidine alone...
    Secondary therapy:
    azacitidine; decitabine
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    AbbVie Press Release
    Title:

    Health Canada Approves VENCLEXTA (venetoclax) in combination with azacitidine or low dose cytarabine for untreated Acute Myeloid Leukemia (AML)

    Published date:
    12/15/2020
    Excerpt:
    AbbVie...announced today that Health Canada has approved VENCLEXTA (venetoclax) in combination with azacitidine or low-dose cytarabine (LDAC) for the treatment of newly-diagnosed acute myeloid leukemia (AML)...
    Secondary therapy:
    azacitidine; cytarabine
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    10/16/2020
    Excerpt:
    VENCLEXTA is a BCL-2 inhibitor indicated: In combination with azacitidine, or decitabine, or low-dose cytarabine for the treatment of newly diagnosed acute myeloid leukemia (AML) in adults 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy.
    Secondary therapy:
    decitabine; cytarabine; azacitidine
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    PharmaTimes
    Title:

    NICE recommend venetoclax and azacytidine for patients with aggressive blood cancer

    Published date:
    12/16/2021
    Excerpt:
    NICE have published a positive Final Appraisal Document recommending routine NHS use of venclyxto (venetoclax) with azacytidine for the treatment of aggressive blood cancer acute myeloid leukaemia (AML).
    Secondary therapy:
    azacitidine
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NCCN
    Published date:
    10/14/2020
    Excerpt:
    Acute Myeloid Leukemia (Age ≥18 years): Venetoclax and azacitidine noted as category 1 and preferred…AML without actional mutation...Venetoclax and decitabine noted as category 1 and preferred
    Secondary therapy:
    decitabine; azacitidine
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Roche Press Release
    Title:

    Roche announces positive CHMP opinion for Venclyxto-based combinations in certain patients with acute myeloid leukaemia

    Published date:
    04/23/2021
    Excerpt:
    ...the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for Venclyxto® (venetoclax) in combination with a hypomethylating agent for the treatment of adult patients with newly diagnosed acute myeloid leukaemia (AML)....The positive recommendation is based on results from the phase III VIALE-A...Results of the VIALE-A study showed Venclyxto plus azacitidine significantly reduced the risk of death by 34% (overall survival; OS), compared to azacitidine alone...
    Secondary therapy:
    azacitidine
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    N Engl J Med
    Title:

    Azacitidine and Venetoclax in Previously Untreated Acute Myeloid Leukemia

    Published date:
    08/13/2020
    Excerpt:
    In previously untreated patients who were ineligible for intensive chemotherapy, overall survival was longer and the incidence of remission was higher among patients who received azacitidine plus venetoclax than among those who received azacitidine alone.
    Secondary therapy:
    azacitidine
    DOI:
    10.1056/NEJMoa2012971
    Trial ID:
    Viale-a
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    AbbVie Press Release
    Title:

    VENCLEXTA®/VENCLYXTO® (venetoclax) Plus Azacitidine Demonstrates Statistically Significant Overall Survival Benefit and Improved Remission Rates in Treatment-Naïve Acute Myeloid Leukemia Patients

    Published date:
    06/13/2020
    Excerpt:
    AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced the positive results from the VIALE-A (M15-656) trial, which demonstrated that previously-untreated patients with acute myeloid leukemia (AML) who were ineligible for intensive chemotherapy treated with venetoclax (VENCLEXTA® or VENCLYXTO®) plus azacitidine achieved a 34 percent reduction in the risk of death...Patients receiving the venetoclax combination achieved improved median overall survival (OS) (14.7 months versus 9.6 months in the placebo arm), and 66.4 percent of patients treated with venetoclax plus azacitidine had a composite complete remission (CR + CRi) compared to 28.3 percent treated with azacitidine plus placebo.
    Secondary therapy:
    azacitidine
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    J Clin Oncol
    Title:

    A phase III study of venetoclax plus low-dose cytarabine in previously untreated older patients with acute myeloid leukemia (VIALE-C): A six-month update.

    Published date:
    05/25/2020
    Excerpt:
    VEN+LDAC demonstrates a clinically meaningful improvement in OS compared with PBO+LDAC, with a tolerable and manageable safety profile. These data support VEN+LDAC as a frontline treatment option for older pts with AML, as well as those considered unfit for intensive chemotherapy.
    Secondary therapy:
    cytarabine
    DOI:
    10.1200/JCO.2020.38.15_suppl.7511
    Trial ID:
    VIALE-C
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Roche Press Release
    Title:

    FDA grants breakthrough therapy designation for Venclexta in acute myeloid leukaemia

    Published date:
    07/28/2017
    Excerpt:
    Roche...announced that the US Food and Drug Administration (FDA) has granted breakthrough therapy designation for Venclexta (venetoclax) in combination with low dose cytarabine (LDAC) for elderly patients with previously untreated AML who are ineligible for intensive chemotherapy.
    Secondary therapy:
    cytarabine