The Food and Drug Administration (FDA) has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for the treatment of HER2-overexpressing breast cancer.

Herceptin Hylecta is a combination of trastuzumab, an HER2/neu receptor antagonist, and hyaluronidase, an endoglycosidase used to increase the dispersion and absorption of coadministered drugs when administered subcutaneously. The product contains the same active ingredient as Herceptin (trastuzumab; Genentech) but is administered by subcutaneous (SC) injection.

Specifically, Herceptin Hylecta is indicated for adjuvant treatment of adults with HER2 overexpressing node positive or node negative (ER/PR negative or with 1 high risk feature) breast cancer: as part of a treatment regimen consisting of doxorubicin, cyclophosphamide, and either paclitaxel or docetaxel; or as part of a treatment regimen with docetaxel and carboplatin; or as a single agent following multi-modality anthracycline based therapy. In addition, it is indicated for use in combination with paclitaxel for first-line treatment of HER2-overexpressing metastatic breast cancer and as a single agent for treatment of HER2-overexpressing breast cancer in patients who have received 1 or more chemotherapy regimens for metastatic disease. Patients should be selected for therapy based on an FDA-approved companion diagnostic for trastuzumab.

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The approval of Herceptin Hylecta was based on 3 studies in which efficacy, safety, and tolerability of the SC product were evaluated. In the phase 3 HannaH study, the SC administration of Herceptin Hylecta was found to be non-inferior to Herceptin administered intravenously (IV) with regard to efficacy as well as pharmacokinetics. The SafeHER study, which evaluated safety and tolerability, found the safety profile of Herceptin Hylecta to be consistent with that of the IV formulation. In addition, more patients preferred the SC treatment over IV therapy in the PrefHER study

“Over the past 20 years, Herceptin has significantly advanced treatment of HER2-positive breast cancer,” said Sandra Horning, MD, chief medical officer and head of Global Product Development. “The approval of Herceptin Hylecta gives physicians and patients in the United States a new option to select treatment based on individual needs and preferences.”

Herceptin Hylecta is a ready-to-use formulation; the dose is administered subcutaneously over approximately 2–5 minutes. The product will be supplied as a single-dose vial containing trastuzumab 600mg and hyaluronidase 10,000 units per 5mL (120mg/2000 units per mL).

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