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    Association details:
    Biomarker:NRG1 fusion
    Cancer:Pancreatic Ductal Adenocarcinoma
    Drug:Bizengri (zenocutuzumab-zbco) (HER2 inhibitor, HER3 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Title:

    FDA grants accelerated approval to zenocutuzumab-zbco for non-small cell lung cancer and pancreatic adenocarcinoma

    Published date:
    12/04/2024
    Excerpt:
    On December 4, 2024, the Food and Drug Administration granted accelerated approval to zenocutuzumab-zbco (Bizengri, Merus N.V.) for adults with the following...advanced, unresectable, or metastatic pancreatic adenocarcinoma harboring a NRG1 gene fusion with disease progression on or after prior systemic therapy.
    Trial ID:
    eNRGy
    Evidence Level:
    Sensitive: B - Late Trials
    Source:
    GlobeNewswire
    Title:

    Merus Announces U.S. FDA Acceptance and Priority Review of Biologics License Application for Zeno for the Treatment of NRG1+ NSCLC and PDAC

    Published date:
    05/06/2024
    Excerpt:
    ...the U.S. Food and Drug Administration (FDA) has accepted for priority review a Biologics License Application (BLA) for the bispecific antibody zenocutuzumab (Zeno) in patients with neuregulin 1 fusion (NRG1+) non-small cell lung (NSCLC) and NRG1+ pancreatic (PDAC) cancer.
    Evidence Level:
    Sensitive: C3 – Early Trials
    Source:
    ESMO 2023
    Title:

    1618P - Durable efficacy of zenocutuzumab, a HER2 x HER3 bispecific antibody, in advanced NRG1 fusion positive (NRG1+) pancreatic ductal adenocarcinoma (PDAC)

    Published date:
    10/16/2023
    Excerpt:
    In this updated analysis, Zeno continues to demonstrate unprecedented efficacy in pts with previously treated advanced/metastatic NRG1+ PDAC with robust and durable responses and a well-tolerated safety profile.
    Trial ID:
    eNRGy