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    Association details:
    Biomarker:Chr del(17p)
    Cancer:Chronic Lymphocytic Leukemia
    Drug:Venclexta (venetoclax) (Bcl2 inhibitor) +
    Gazyva (obinutuzumab) (CD20 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Scottish Medicines Consortium
    Title:

    Venetoclax (Venclyxto®) is accepted for restricted use within NHSScotland.

    Published date:
    11/06/2020
    Excerpt:
    Venetoclax (Venclyxto®) is accepted for restricted use within NHSScotland....: In combination with obinutuzumab for the treatment of adult patients with previously untreated chronic lymphocytic leukaemia (CLL)....for use in (1) patients without del (17p)/TP53 mutation who are not fit to receive FCR (fludarabine, cyclophosphamide and rituximab) chemo-immunotherapy and (2) patients with del (17p)/TP53 mutation.
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    NICE
    Title:

    NICE recommends new chemotherapy-free treatment option for people with untreated chronic lymphocytic leukaemia

    Published date:
    11/10/2020
    Excerpt:
    NICE has...recommended a new chemotherapy-free treatment option for people with untreated chronic lymphocytic leukaemia (CLL)...Venetoclax plus obinutuzumab will be offered as a first-line treatment to people with CLL, with certain genetic abnormalities (such as a 17p deletion or TP53 mutation).
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    NCCN
    Excerpt:
    Suggested treatment regimens...CLL/SLL with del(17p)/TP53 mutation…first line therapy…preferred regimen…Venetoclax ± obinutuzumab
    Evidence Level:
    Sensitive: A2 - Guideline
    New
    Source:
    ESMO.org
    Title:

    Chronic lymphocytic leukaemia: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up

    Excerpt:
    Recommendations: TP53 mutation or del(17p): ibrutinib or acalabrutinib or venetoclax plus obinutuzumab or venetoclax alone or idelalisib plus rituximab [III, A].
    DOI:
    10.1016/j.annonc.2020.09.019
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    ICML 2021
    Title:

    030 | GENETIC MARKERS AND OUTCOME WITH FRONT LINE OBINUTUZUMAB PLUS EITHER CHLORAMBUCIL OR VENETOCLAX - UPDATED ANALYSIS OF THE CLL14 TRIAL

    Published date:
    06/09/2021
    Excerpt:
    CONTRADICTED EVIDENCE:...OS was shorter with del(17p) and TP53 mutation in both treatment arms (GClb: HR 5.7 and HR 3.1, VenG: HR 3.5 and HR 3.0, all p < 0.01) and with mutated SF3B1 (HR 2.0, p = 0.05)…
    DOI:
    https://doi.org/10.1002/hon.2879
    Trial ID:
    CLL14 study
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    EHA 2021
    Title:

    GENETIC MARKERS AND OUTCOME IN FRONT LINE OBINUTUZUMAB PLUS CHLORAMBUCIL OR VENETOCLAX - UPDATED ANALYSIS OF THE CLL14 TRIAL

    Published date:
    05/12/2021
    Excerpt:
    CONTRADICTING EVIDENCE:…gene mutations in the CLL14 trial comparing obinutuzumab+chlorambucil (GClb) vs. obinutuzumab+venetoclax (VenG) in 432 patients (1:1) with CIRS>6 and/or creatinine clearance < 70 ml/min….Overall survival (OS) was shorter with del(17p) and TP53 mutation in both treatment arms (GClb: HR 5.7 and HR 3.1, VenG: HR 3.5 and HR 3.0, all p<0.01)…
    Trial ID:
    CLL14 study
    Test:
    clonoSEQ