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    Association details:
    Biomarker:HER-2 overexpression
    Cancer:Breast Cancer
    Drug:Hercessi (trastuzumab-strf) (HER2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    PRNewswire
    Title:

    Accord BioPharma, Inc. Announces U.S. Food & Drug Administration Approval of 420mg Strength of HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), for the Treatment of Several Forms of HER2-Overexpressing Cancer

    Published date:
    09/18/2024
    Excerpt:
    ...the U.S. Food and Drug Administration (FDA) has approved a 420mg strength of HERCESSI™ (trastuzumab-strf), a biosimilar to Herceptin® (trastuzumab), to treat HER2-overexpressing breast and gastric or gastroesophageal junction adenocarcinoma.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    07/27/2020
    Excerpt:
    Zercepac should only be used in patients with metastatic or early breast cancer whose tumours have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.
    Secondary therapy:
    docetaxel; paclitaxel; Aromatase inhibitor