Herceptin Hylecta Approved for Breast Cancer
February 28, 2019 – The U.S. FDA has approved Herceptin Hylecta™ (trastuzumab/hyaluronidase-oysk), manufactured by Genentech, for the treatment of HER2-overexpressing breast cancer. Unlike Herceptin® (trastuzumab), Herceptin Hylecta is a fixed-dose combination product for subcutaneous injection.
The new product uses a proprietary recombinant human hyaluronidase enzyme (ENHANZE® technology) from Halozyme. This allows it to be administered subcutaneously over the course of two to five minutes. Standard Herceptin requires a 30- to 90-minute intravenous (IV) infusion.
Recommended dosing is 600mg trastuzumab/10,000 units hyaluronidase administered once every three weeks. Like all trastuzumab products, Herceptin Hylecta has a black box warning for pulmonary toxicity, cardiomyopathy, and embryo-fetal toxicity.
Genentech plans to launch Herceptin Hylecta in April 2019.