Posted from: Monday, April 08, 2019 - 04:14 PM - Present

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.

Last Updated Friday, June 14, 2019 - 09:22 PM.