FDA Approves Under-the-skin Formulation of Herceptin for Certain Breast Cancers

FDA Approves Under-the-skin Formulation of Herceptin for Certain Breast Cancers
The U.S. Food and Drug Administration (FDA) has approved an under-the-skin formulation of Genentech's breast cancer treatment Herceptin (trastuzumab), called Herceptin Hylecta. Also by Genentech, the treatment consists of a combination of trastumuzab and recombinant human hyaluronidase PH20, a protein that helps deliver the antibody under the skin. "Over the past 20 years, Herceptin has significantly advanced treatment of HER2-positive breast cancer," Sandra Horning, MD, Genentech's chief medical officer and head of global product development, said in a press release. "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." The new treatment contains trastuzumab, the same antibody used in intravenous Herceptin, which targets the HER2 protein — involved in breast cancer growth and survival — and the recombinant human hyaluronidase PH20 — an enzyme that temporarily destroys large sugar molecules in the body, facilitating trastuzumab delivery under the skin. This recombinant enzyme is part of the proprietary drug delivery technology Enhanze, developed by Halozyme Therapeutics. As a result, unlike the standard intravenous injections of Herceptin that could take between 30 to 90 minutes to ad
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