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1 Indications And Usage Ogivri Is A Her2/neu Receptor Antagonist Indicated For: • The Treatment Of Her2-Overexpressing Breast Cancer. ( 1.1 , 1.2 ) • The Treatment Of Her2-Overexpressing Metastatic Gastric Or Gastroesophageal Junction Adenocarcinoma. ( 1.3 ) Select Patients For Therapy Based On An Fda-Approved Companion Diagnostic For A Trastuzumab Product ( 1 , 2.1 ). 1.1 Adjuvant Breast Cancer Ogivri Is Indicated For Adjuvant Treatment Of Her2 Overexpressing Node Positive Or Node Negative (Er/pr Negative Or With One High Risk Feature [See Clinical Studies (14.1) ] ) Breast Cancer • As Part Of A Treatment Regimen Consisting Of Doxorubicin, Cyclophosphamide, And Either Paclitaxel Or Docetaxel • As Part Of A Treatment Regimen With Docetaxel And Carboplatin • As A Single Agent Following Multi-Modality Anthracycline Based Therapy. Select Patients For Therapy Based On An Fda-Approved Companion Diagnostic For A Trastuzumab Product [See Dosage And Administration (2.1) ]. 1.2 Metastatic Breast Cancer Ogivri Is Indicated: • In Combination With Paclitaxel For First-Line Treatment Of Her2-Overexpressing Metastatic Breast Cancer • As A Single Agent For Treatment Of Her2-Overexpressing Breast Cancer In Patients Who Have Received One Or More Chemotherapy Regimens For Metastatic Disease. Select Patients For Therapy Based On An Fda-Approved Companion Diagnostic For A Trastuzumab Product [See Dosage And Administration (2.1) ]. 1.3 Metastatic Gastric Cancer Ogivri Is Indicated, In Combination With Cisplatin And Capecitabine Or 5-Fluorouracil, For The Treatment Of Patients With Her2-Overexpressing Metastatic Gastric Or Gastroesophageal Junction Adenocarcinoma Who Have Not Received Prior Treatment For Metastatic Disease. Select Patients For Therapy Based On An Fda-Approved Companion Diagnostic For A Trastuzumab Product [See Dosage And Administration (2.1) ] .
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