FDA approves Herceptin Hylecta

The US Food and Drug Administration has approved 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.

This new treatment from Swiss pharma giant Roche (ROG: SIX) includes the same monoclonal antibody as the company's blockbuster intravenous Herceptin (trastuzumab) – now facing up to biosimilars competition - in combination with recombinant human hyaluronidase PH20, an enzyme that helps to deliver trastuzumab under the skin. 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 Herceptin.

Herceptin Hylecta is a co-formulation of trastuzumab with Halozyme Therapeutics' (Nasdaq: HALO) proprietary recombinant human hyaluronidase enzyme (ENHANZE) technology, which Roche first in-licensed in 2006.