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    Association details:
    Biomarker:No biomarker
    Cancer:Squamous Cell Carcinoma of Head and Neck
    Drug:Opdivo (nivolumab) (PD1 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Bristol-Myers Squibb Press Release
    Title:

    HEALTH CANADA APPROVES OPDIVO(NIVOLUMAB) FOR THE TREATMENT OF SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK

    Published date:
    05/17/2017
    Excerpt:
    Health Canada has approved OPDIVO (nivolumab) for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) in adults progressing on or after platinum-based therapy– the first and only immuno-oncology treatment in Canada for this indication.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    06/19/2015
    Excerpt:
    OPDIVO as monotherapy is indicated for the treatment of recurrent or metastatic squamous cell cancer of the head and neck in adults progressing on or after platinum-based therapy.
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    FDA
    Excerpt:
    OPDIVO is a programmed death receptor-1 (PD-1) blocking antibody indicated for the treatment of...patients with recurrent or metastatic squamous cell carcinoma of the head and neck with disease progression on or after a platinum-based therapy.
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    ASCO.org
    Title:

    Immunotherapy and Biomarker Testing in Recurrent and Metastatic Head and Neck Cancers: ASCO Guideline

    Published date:
    12/15/2022
    Excerpt:
    Immunotherapy and Biomarker Testing in Recurrent and Metastatic Head and Neck Cancers....Recommendation 3.1….Pembrolizumab or nivolumab should be offered to patients with platinum-refractory recurrent or metastatic HNSCC, regardless of CPS status
    DOI:
    10.1200/JCO.22.02328
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    PharmaTimes
    Title:

    NICE backs Opdivo for head and neck cancer

    Published date:
    09/15/2021
    Excerpt:
    The National Institute for Health and Care Excellence (NICE) has recommended Bristol Myers Squibb’s (BMS) immunotherapy Opdivo (nivolumab) for routine use on the NHS as a treatment for metastatic and recurrent head and neck cancer...In January, NICE published draft guidance in which it turned down Opdivo for the treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) after platinum-based chemotherapy.
    Evidence Level:
    Sensitive: A2 - Guideline
    Source:
    ESMO.org
    Title:

    Squamous cell carcinoma of the oral cavity, larynx, oropharynx and hypopharynx: EHNS-ESMO-ESTRO Clinical Practice Guidelines for diagnosis, treatment and follow-up

    Published date:
    11/01/2020
    Excerpt:
    Nivolumab is both FDA- and EMA-approved for recurrent/metastatic patients who progress within 6 months of platinum therapy [I, A; ESMO-MCBS v1.1 score: 4].
    DOI:
    10.1016/j.annonc.2020.07.011
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Cancers (Basel)
    Title:

    Phase 4 Multinational Multicenter Retrospective and Prospective Real-World Study of Nivolumab in Recurrent and Metastatic Squamous Cell Carcinoma of the Head and Neck

    Published date:
    07/09/2023
    Excerpt:
    The median rwOS was 9.2 months. Among patients with at least one assessment, 21.7% reported their best response as 'partial response', with 3.9% reporting 'complete response'. The median duration of response (DoR) and median rwPFS were 11.0 months and 3.9 months, respectively....This real-world, multinational, multicenter, retrospective and prospective study supports the effectiveness and safety of nivolumab for R/M SCCHN patients.
    DOI:
    10.3390/cancers15143552