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# Genentech’s Herceptin Hylecta Approved for Breast Cancer
- URL: https://www.fdaweb.com/genentechs-herceptin-hylecta-approved-for-breast-cancer/
- Published: 2019-02-28T12:00:00.000Z
- Updated: 2026-09-15T01:08:38.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143500

FDA has approved Genentech’s Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) subcutaneous injection for treating patients with HER2-positive early breast cancer (node-positive, or node-negative and ER/PR-negative or with one high-risk feature) in combination with chemotherapy and HER2-positive metastatic breast cancer in combination with paclitaxel or alone in people who have received one or more chemotherapy regimens for metastatic disease. The new treatment includes the same monoclonal antibody as intravenous Herceptin in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under the skin. Herceptin Hylecta is a ready-to-use formulation that can be administered in two to five minutes, compared to 30 to 90 minutes for intravenous Herceptin, according to the company.