What is the generic name?

TRASTUZUMAB AND HYALURONIDASE-OYSK

What is the Trade Name for TRASTUZUMAB AND HYALURONIDASE-OYSK?

Herceptin Hylecta

What are the Indications for TRASTUZUMAB AND HYALURONIDASE-OYSK?

• 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) ] .

References: https://open.fda.gov/