Subcutaneous Herceptin approved in EU
This article was originally published in Scrip
Executive Summary
San Diego-based Halozyme Therapeutics has been granted European marketing authorization from the European Commission for a subcutaneous formulation of Roche's Herceptin (trastuzumab), which contains Halozyme's recombinant human hyaluronidase (rHuPH20). The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended approval of the extension in early July 2013 (scripintelligence.com, 1 July 2013). The approval applies to all lines of treatment for women with HER2-positive breast cancer, but does not apply to gastric cancer labeling for intravenous Herceptin. The EC's decision was based on data from the HannaH study.