The subcutaneous formulation of Herceptin SC (trastuzumab) has been approved for the treatment of patients with HER2-positive breast cancer by Health Canada.
The new delivery form of trastuzumab was created by Roche using Halozyme’s recombinant human hyaluronidase enzyme technology, known as Enhanze.
The enzyme technology allows for a higher volume of biologics that can be delivered subcutaneously. The technology uses rHuPH20, an enzyme which can allow for biologics and compounds that are traditionally delivered intravenously (IV) to be delivered subcutaneously.
Helen Torley, CEO of Halozyme told us, “For patients, the subcutaneous version offers the potential for reduced treatment burden as a result of the shorter injection than when patients receive Herceptin via the IV route.”
Genetech, a subsidiary of Roche, submitted a biologics license application for a subcutaneous formulation of the drug, which was received by the US Food and Drug Administration in July of 2018.
Torley further explained, “In the countries where it has been launched, the subcutaneous version was recently reported by Roche, at peak, to account for [roughly] 60% of total sales volume, with IV Herceptin accounting for [roughly] 40%.”