Application Nr Approved Date Route Status External Links
BLA761106 None Subcutaneous None Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Herceptin Hylecta Is A Combination Of Trastuzumab, A Her2/neu Receptor Antagonist, And Hyaluronidase, An Endoglycosidase, Indicated In Adults For: The Treatment Of Her2-Overexpressing Breast Cancer. ( 1.1 , 1.2 ) Select Patients For Therapy Based On An Fda-Approved Companion Diagnostic For Trastuzumab. ( 1 , 2.1 ) 1.1 Adjuvant Breast Cancer Herceptin Hylecta Is Indicated For Adjuvant Treatment Of Adults With 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 Trastuzumab [See Dosage And Administration (2.1) ] . 1.2 Metastatic Breast Cancer Herceptin Hylecta Is Indicated In Adults: 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 Trastuzumab [See Dosage And Administration (2.1) ] .

All Formulated Excipients (0 Total)

None

Active Ingredients ( 2 Total)

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