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Thursday, February 28, 2019

Halozyme announces FDA approval of Herceptin Hylecta

Halozyme Therapeutics announced that Genentech, a member of the Roche Group, has received approval from the 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 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. 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.
https://thefly.com/landingPageNews.php?id=2872375

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