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    Association details:
    Biomarker:No biomarker
    Cancer:Renal Cell Carcinoma
    Drug:Bavencio (avelumab) (PD-L1 inhibitor) +
    Inlyta (axitinib) (VEGFR inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    12/12/2020
    Excerpt:
    Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    Scottish Medicines Consortium
    Title:

    Avelumab (Bavencio®) is accepted for use within NHSScotland.

    Published date:
    10/12/2020
    Excerpt:
    Avelumab in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    09/18/2017
    Excerpt:
    Bavencio in combination with axitinib is indicated for the first-line treatment of adult patients with advanced renal cell carcinoma (RCC).
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Published date:
    03/23/2017
    Excerpt:
    BAVENCIO is a programmed death ligand-1 (PD-L1) blocking antibody indicated for:...First-line treatment, in combination with axitinib, of patients with advanced RCC.
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    J Clin Oncol
    Title:

    Efficacy of avelumab plus axitinib (A + Ax) versus sunitinib (S) by number of IMDC risk factors and tumor sites at baseline in advanced renal cell carcinoma (aRCC): Extended follow-up results from JAVELIN Renal 101.

    Published date:
    02/20/2021
    Excerpt:
    ...median (m) follow-up for OS and PFS was 19.3 vs 19.2 mo and 16.8 vs 15.2 mo for the A + Ax vs S arm...A + Ax generally demonstrated efficacy benefit vs S across the number of IMDC risk factors and tumor sites at baseline in aRCC.
    DOI:
    10.1200/JCO.2021.39.6_suppl.302
    Trial ID:
    JAVELIN Renal 101
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    N Engl J Med
    Title:

    Avelumab plus Axitinib versus Sunitinib for Advanced Renal-Cell Carcinoma

    Published date:
    03/21/2019
    Excerpt:
    Progression-free survival was significantly longer with avelumab plus axitinib than with sunitinib among patients who received these agents as first-line treatment for advanced renal-cell carcinoma.
    DOI:
    10.1056/NEJMoa1816047
    Trial ID:
    JAVELIN Renal 101
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Pfizer Press Release
    Title:

    FDA ACCEPTS SBLA AND GRANTS PRIORITY REVIEW FOR BAVENCIO® (AVELUMAB) PLUS INLYTA (AXITINIB) FOR THE TREATMENT OF ADVANCED RENAL CELL CARCINOMA

    Published date:
    02/11/2019
    Excerpt:
    EMD Serono...announced that the US Food and Drug Administration (FDA) has accepted for Priority Review the supplemental Biologics License Application (sBLA) for BAVENCIO (avelumab) in combination with INLYTA (axitinib) for patients with advanced renal cell carcinoma (RCC).
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    Merck (MSD) Press Release
    Title:

    FDA Grants Breakthrough Therapy Designation for Avelumab in Combination with INLYTA in Advanced Renal Cell Carcinoma

    Published date:
    12/21/2017
    Excerpt:
    Merck and Pfizer...announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for avelumab in combination with INLYTA (axitinib) for treatment-naïve patients with advanced renal cell carcinoma (RCC).