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    DRUG:

    Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)

    i
    Other names: RG597 (SC formulation), trastuzumab SC, reformulated Herceptin
    Company:
    Halozyme, Roche
    Drug class:
    HER2 inhibitor
    Related drugs:
    1d
    Real-world evidence on the use of hospital resources for subcutaneous and intravenous trastuzumab administration in breast cancer patients at a referral public hospital in Mexico. (PubMed, J Comp Eff Res)
    In a routine public oncology setting with limited resources, the use of SC trastuzumab was associated with clear advantages in terms of efficiency and the treatment experience while also mitigating the workload of infusion areas. These results provide practical, context-specific evidence that could help healthcare systems to improve the organization of oncology services and make better use of scarce hospital resources.
    Journal • HEOR • Real-world evidence
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
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    Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    7d
    A Study of Subcutaneous Trastuzumab Deruxtecan in Participants With Metastatic Solid Tumors (clinicaltrials.gov)
    P1, N=25, Recruiting, Daiichi Sankyo
    New P1 trial
    |
    HER-2 positive • HER-2 mutation
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    Enhertu (fam-trastuzumab deruxtecan-nxki) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    13d
    A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers (clinicaltrials.gov)
    P1, N=150, Recruiting, Biocon Biologics UK PLC | Not yet recruiting --> Recruiting
    Enrollment open
    |
    Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    21d
    Updated cost comparison of home care subcutaneous versus outpatient intravenous trastuzumab for HER2-positive breast cancer in Singapore. (PubMed, Ther Adv Med Oncol)
    While service delivery (manpower, facility, consumables) and productivity loss remained cheaper in home care, drug cost is the dominant factor of overall expenditure in trastuzumab delivery. At current drug prices, outpatient IV trastuzumab administration is the cost-saving option, compared with home care SC trastuzumab.
    Reimbursement • US reimbursement • Journal • HEOR
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    2ms
    A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN) (clinicaltrials.gov)
    P2, N=28, Active, not recruiting, Adrienne G. Waks | Recruiting --> Active, not recruiting | N=40 --> 28
    Enrollment closed • Enrollment change
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Trodelvy (sacituzumab govitecan-hziy) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    2ms
    A Single-arm Phase II Trial of SAcituzumab Govitecan and Trastuzumab for HER2+ Metastatic Breast Cancer After Trastuzumab dEruxtEcaN (SATEEN) (clinicaltrials.gov)
    P2, N=40, Recruiting, Adrienne G. Waks | Trial primary completion date: Nov 2026 --> Feb 2026
    Trial primary completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Trodelvy (sacituzumab govitecan-hziy) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    2ms
    DS8201-801: Subcutaneous Trastuzumab Deruxtecan Phase 1 Trial. (2024-516625-31-00)
    P1, N=20, Recruiting, Daiichi Sankyo Inc.
    New P1 trial
    |
    Enhertu (fam-trastuzumab deruxtecan-nxki) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    3ms
    Reducing treatment burden in HER2+ breast cancer: Evaluating subcutaneous injection methods for pertuzumab/trastuzumab combination therapy. (PubMed, Medicine (Baltimore))
    This retrospective analysis suggests that using a slow bolus injection with an infusion pump may reduce local adverse reactions following subcutaneous administration of pertuzumab and trastuzumab in patients with HER2-positive breast cancer. The standardized use of infusion pumps could enhance patient comfort, safety, and overall treatment experience.
    Observational data • Retrospective data • Journal
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    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Perjeta (pertuzumab) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    3ms
    Subcutaneous versus intravenous trastuzumab for HER2-positive breast cancer: a global systematic review and meta-analysis with a cost-minimization analysis from the Chinese healthcare system perspective. (PubMed, Front Pharmacol)
    These findings are particularly relevant to healthcare systems where SC formulations are newly introduced, providing timely evidence to guide patient-centered clinical decision-making. https://www.crd.york.ac.uk/prospero/display_record.php?RecordID=637674, identifier CRD42025637674.
    Retrospective data • Review • Journal • HEOR
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive
    |
    Herceptin (trastuzumab) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    3ms
    A Study of Tucatinib (MK-7119) in Combination With Trastuzumab and Capecitabine in Participants With Previously Treated Locally Advanced Unresectable or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Carcinoma (MK-7119-001) (clinicaltrials.gov)
    P2, N=66, Active, not recruiting, Pfizer | Trial completion date: Nov 2025 --> Jun 2026
    Trial completion date
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    capecitabine • Tukysa (tucatinib) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    4ms
    Efficacy and Safety of Subcutaneous Pertuzumab-Trastuzumab (Phesgo) in Neoadjuvant Treatment of HER2-positive Breast Cancer: Real-world Data from Japan. (PubMed, Anticancer Res)
    Phesgo demonstrated comparable or superior efficacy and favorable safety with markedly improved treatment efficiency in real-world Japanese practice. Phesgo represents a promising alternative to intravenous administration, reducing patient burden and optimizing healthcare resource utilization.
    Retrospective data • Journal • Real-world evidence
    |
    HER-2 (Human epidermal growth factor receptor 2)
    |
    HER-2 positive • HR positive
    |
    Perjeta (pertuzumab) • Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) • Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)
    4ms
    A Phase 1 Comparative Study to Evaluate Pharmacokinetics, Immunogenicity, Safety and Tolerability of Bmab3000 and Herceptin Hylecta® After a Single 600 mg SC Injection in Healthy Male Volunteers (clinicaltrials.gov)
    P1, N=150, Not yet recruiting, Biocon Limited
    New P1 trial
    |
    Herceptin Hylecta (trastuzumab/hyaluronidase-oysk)