Posted by Michael Wonder on 28 Feb 2019
FDA approves Herceptin Hylecta for subcutaneous injection in certain HER2-positive breast cancers
28 February 2019 - Genentech today announced the U.S. FDA has approved Herceptin Hylecta (trastuzumab and hyaluronidase-oysk) for subcutaneous injection for the treatment of certain people 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.
This new treatment includes the same monoclonal antibody as intravenous Herceptin (trastuzumab) 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.
The FDA approval is based on results from three clinical studies in HER2-positive early breast cancer.
