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    Association details:
    Biomarker:HER-2 overexpression
    Cancer:Gastric Cancer
    Drug:Ogivri (trastuzumab-dkst) (HER2 inhibitor)
    Direction:Sensitive
    Evidence:
    Evidence Level:
    Sensitive: A1 - Approval
    New
    Source:
    Biocon Press Release
    Title:

    Health Canada Approves Biocon and Mylan’s Ogivri™, the First Trastuzumab Biosimilar, for the Treatment of HER2-Positive Breast and Gastric Cancers

    Published date:
    05/22/2019
    Excerpt:
    Biocon Ltd. and Mylan N.V. today announced that Health Canada has approved Mylan’s Ogivri™ (trastuzumab), a biosimilar to Herceptin1 (trastuzumab) co-developed with Biocon, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma).
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    European Medicines Agency
    Published date:
    12/12/2018
    Excerpt:
    Ogivri should only be used in patients with metastatic gastric cancer (MGC) whose tumours have HER2 overexpression as defined by IHC2+ and a confirmatory SISH or FISH result, or by an IHC 3+ result.
    Evidence Level:
    Sensitive: A1 - Approval
    Source:
    FDA
    Excerpt:
    Ogivri is a HER2/neu receptor antagonist indicated for...the treatment of HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.