Roche announced that the European Commission (EC) has approved its new subcutaneous formulation of Herceptin (trastuzumab) for the treatment of early- and late-stage HER2-positive breast cancer. The new subcutaneous formulation can be administered six times faster, taking only 2 min to 5 min compared with the standard intravenous formulation, which is given over 30 min to 90 min. This advantage enables patients to spend less time receiving Herceptin treatment in hospital.
Roche’s new subcutaneous Herceptin is a ready-to-use liquid formulation that is administered as a 600 mg/5 mL fixed dose every three weeks. There is no need for reconstitution or dose calculation based on the patient’s body weight, hence making healthcare procedures simpler. Moreover, a loading dose is not required for subcutaneous administration.
The subcutaneous formulation uses a technology developed by Halozyme Therapeutics, which temporarily and reversibly degrades hyaluronan, a gel-like substance that forms a barrier between cells under the skin. By doing so, the 5 mL volume of the subcutaneous formulation of Herceptin can be rapidly dispersed and absorbed over a greater area.
Approval was based on results from the HannaH study, in which the subcutaneous formulation demonstrated comparable safety and efficacy to the intravenous formulation in women with HER2-positive breast cancer.