Roche’s Herceptin Hylecta approved by FDA

The FDA has approved Roche’s 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. The approval is based on results from the phase III HannaH, the phase III SafeHER, and the PrefHER patient preference clinical studies in HER2-positive early breast cancer.
Herceptin Hylecta includes the same monoclonal antibody as intravenous Herceptin in combination with recombinant human hyaluronidase PH20, which requires 30 to 90 minutes for administration, but requires just two to five minutes administration time thanks to its ready-to-use formulation.
Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development, said: “Over the past 20 years, Herceptin has significantly advanced treatment of HER2-positive breast cancer. 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.”