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Ref Type
PMID
Authors
Title Herceptin Hylecta (trastuzumab and hyaluronidase-oysk injection) FDA Drug Label
Journal
Vol
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Date
URL https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=761106
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Molecular Profile Treatment Approach
Gene Name Source Synonyms Protein Domains Gene Description Gene Role
Therapy Name Drugs Efficacy Evidence Clinical Trials
Drug Name Trade Name Synonyms Drug Classes Drug Description
trastuzumab and hyaluronidase-oysk injection Herceptin Hylecta HER2 (ERBB2) Antibody 47 Herceptin Hylecta (trastuzumab and hyaluronidase-oysk injection) is an injectable formulation consists of Herceptin (trastuzumab) and hyaluronidase, which demonstrates anti-tumor activity against ERBB2 (HER2)-positive breast cancer (PMID: 28625777). Herceptin Hylecta (trastuzumab and hyaluronidase-oysk injection) is FDA-approved for use in patients with Erbb2 (Her2)-overexpressing and/or Erbb2 (Her2) amplified breast cancer (FDA.gov).
Gene Variant Impact Protein Effect Variant Description Associated with drug Resistance
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 over exp Her2-receptor positive breast cancer sensitive trastuzumab and hyaluronidase-oysk injection FDA approved - On Companion Diagnostic Actionable In a Phase III trial (HannaH) that supported FDA approval, Herceptin Hylecta (trastuzumab and hyaluronidase-oysk injection) treatment demonstrated safety and efficacy profile comparable to intravenous trastuzumab treatment, resulted in pathologic complete response in 45.4% (118/260) of patients with ERBB2 (HER2)-positive (IHC 3+ or ISH positive) breast cancer (PMID: 22884505; NCT00950300). detail... detail... 22884505
ERBB2 amp Her2-receptor positive breast cancer sensitive trastuzumab and hyaluronidase-oysk injection FDA approved - On Companion Diagnostic Actionable In a Phase III trial (HannaH) that supported FDA approval, Herceptin Hylecta (trastuzumab and hyaluronidase-oysk injection) treatment demonstrated safety and efficacy profile comparable to intravenous trastuzumab treatment, resulted in pathologic complete response in 45.4% (118/260) of patients with ERBB2 (HER2)-positive (IHC 3+ or ISH positive) breast cancer (PMID: 22884505; NCT00950300). detail... detail... 22884505