Halozyme Therapeutics, Inc., a biotechnology company developing novel oncology and drug-delivery therapies, announced that Genentech, a member of the Roche Group, has received approval from the U.S. FDA for Herceptin Hylecta™, a subcutaneous fixed-dose combination of trastuzumab and hyaluronidase-oysk. Herceptin Hylecta™ is approved 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.
Herceptin Hylecta™ is a co-formulation of trastuzumab with Halozyme’s proprietary recombinant human hyaluronidase enzyme (ENHANZE® technology). 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 trastuzumab.
“We are delighted that Herceptin Hylecta™ has been approved in the U.S. and that the potential for two- to five-minute administration time will now be available to patients in most of the major developed markets,” said Dr. Helen Torley, president and chief executive officer. “Herceptin Hylecta™ is the third product co-formulated with ENHANZE to receive FDA approval, which represents an important achievement.”
About ENHANZE® Technology
Halozyme’s proprietary ENHANZE® drug-delivery technology is based on its patented recombinant human hyaluronidase enzyme (rHuPH20). rHuPH20 has been shown to remove traditional limitations on the volume of biologics that can be delivered subcutaneously (just under the skin). By using rHuPH20, some biologics and compounds that are administered intravenously may instead be delivered subcutaneously. ENHANZE® may also benefit subcutaneous biologics by reducing the need for multiple injections. This delivery has been shown in studies to reduce health care practitioner time required for administration and shorten time for drug administration.
Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme’s lead proprietary program, investigational drug pegvorhyaluronidase alfa (PEGPH20), applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for the treatment of several cancers and has the potential to be used in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb, Alexion and argenx for its ENHANZE® drug delivery technology. Halozyme is headquartered in San Diego. For more information visit www.halozyme.com.